Cardinal Health 200, LLC recalls
62 recalls in our records from 2016 to 2026: 61 FDA medical devices, 1 FDA drugs.
Recalls with full detail pages
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Cardinal Health 200, LLC drug recall: Webcol Alcohol Prep pad
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Earlier and other recalls
These link to the official agency notice.
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Cardinal Health 200, LLC medical device recall: Presource Packs containing Medtronic Microstream Components:… Official notice ↗
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter…
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Cardinal Health 200, LLC medical device recall: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:… Official notice ↗
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can…
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Cardinal Health 200, LLC medical device recall: Presource Convenience Kits: 1) KIT Official notice ↗
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in…
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Cardinal Health 200, LLC medical device recall: Presource Packs Containing CliniClean Pericare Wipes within BD… Official notice ↗
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a…
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Cardinal Health 200, LLC medical device recall: Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT Official notice ↗
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
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Cardinal Health 200, LLC medical device recall: Cardinal Health Monoject Tuberculin Syringe Official notice ↗
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within…
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Cardinal Health 200, LLC medical device recall: Chest Drainage Units and Accessories: Product Code Description 1.… Official notice ↗
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used…
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Cardinal Health 200, LLC medical device recall: ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus… Official notice ↗
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five…
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Cardinal Health 200, LLC medical device recall: Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit"… Official notice ↗
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of…
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Cardinal Health 200, LLC medical device recall: SCD Comfort Knee Length Small Official notice ↗
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
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Cardinal Health 200, LLC medical device recall: Catalog No. 8888160119 Official notice ↗
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
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Cardinal Health 200, LLC medical device recall: Cardinal Health Presource Kits: 1) KIT Official notice ↗
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
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Cardinal Health 200, LLC medical device recall: Cardinal Health Presource Kits: 1) KIT Official notice ↗
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
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Cardinal Health 200, LLC medical device recall: Convertor Isolation Gown Official notice ↗
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for…
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Cardinal Health 200, LLC medical device recall: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack Official notice ↗
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless…
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Cardinal Health 200, LLC medical device recall: (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube Official notice ↗
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
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Cardinal Health 200, LLC medical device recall: Presource kits and trays Official notice ↗
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit…
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Cardinal Health 200, LLC medical device recall: CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in Official notice ↗
Potential contamination of the product with latex adhesive residual.
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Cardinal Health 200, LLC medical device recall: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain Official notice ↗
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before…
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Cardinal Health 200, LLC medical device recall: Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18… Official notice ↗
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
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Cardinal Health 200, LLC medical device recall: Cardinal Health Monoject Official notice ↗
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding…
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Cardinal Health 200, LLC medical device recall: CardinalHealth Suction Canister Liner Official notice ↗
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a…
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Cardinal Health 200, LLC medical device recall: Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack Official notice ↗
Demonstrated recognition and compatibility issues with syringe infusion pumps.
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Cardinal Health 200, LLC medical device recall: Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack Official notice ↗
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
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Cardinal Health 200, LLC medical device recall: Procedure packs Official notice ↗
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
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Cardinal Health 200, LLC medical device recall: NovaPlus Infant Heel Warmer Official notice ↗
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
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Cardinal Health 200, LLC medical device recall: Presource Kit Official notice ↗
Inadvertently released for distibution without sterility assurance.
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Cardinal Health 200, LLC medical device recall: Cardinal Health Presource Packs IV START KIT- Intended for IV access… Official notice ↗
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to…
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Cardinal Health 200, LLC medical device recall: Cardinal Health Jackson-Pratt Channel Drain Official notice ↗
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of…
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Cardinal Health 200, LLC medical device recall: Cardinal Health GEL PACK REUSABLE Official notice ↗
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on…
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Cardinal Health 200, LLC medical device recall: Cardinal Health PROTEXIS PI and PI Classic Official notice ↗
Product was distributed without being sterilized.
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Cardinal Health 200, LLC medical device recall: Argyle UVC Insertion Tray containing Safety Scalpel N11 Official notice ↗
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that…
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Cardinal Health 200, LLC medical device recall: Infant Heel Warmer with Attachment Tab Official notice ↗
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the…
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Cardinal Health 200, LLC medical device recall: Sterile Femoral Angiography Drape with Single Pouch Official notice ↗
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being…
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Cardinal Health 200, LLC medical device recall: Enteral Infusion Pump Official notice ↗
The potential for air appearing in the enteral feed pumping set tubing during set-up.
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Cardinal Health 200, LLC medical device recall: In-View Clear Leggings Sterile Official notice ↗
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may…
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Cardinal Health 200, LLC medical device recall: Judkins Pack Official notice ↗
Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication…
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Cardinal Health 200, LLC medical device recall: Magellan Hypodermic Safety Needle Official notice ↗
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for…
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Cardinal Health 200, LLC medical device recall: Covidien ChemoPlus Chemo Spill Kit Official notice ↗
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
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Cardinal Health 200, LLC medical device recall: Gown Isolation W/Ties Univ Ylw Official notice ↗
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
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Cardinal Health 200, LLC medical device recall: Kangaroo Connect 500ml Bag Set Official notice ↗
The feeding spike sets may leak at the interface of the tube and spike connector.
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Cardinal Health 200, LLC medical device recall: Covidien MONOJECT Standard Hypodermic Needle Official notice ↗
Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall…
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Cardinal Health 200, LLC medical device recall: Kit Official notice ↗
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
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Cardinal Health 200, LLC medical device recall: PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This… Official notice ↗
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
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Cardinal Health 200, LLC medical device recall: Cardinal Health NPWT Canister with Gel 300cc Official notice ↗
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
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Cardinal Health 200, LLC medical device recall: Monoject 3mL Syringe with Hypodermic Safety Needle Official notice ↗
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is…
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Cardinal Health 200, LLC medical device recall: Presource Procedure Packs containing AAMI Level 3 surgical gowns Official notice ↗
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that…
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Cardinal Health 200, LLC medical device recall: Presource Procedure Packs containing AAMI Level 3 surgical gowns Official notice ↗
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that…
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Cardinal Health 200, LLC medical device recall: Genius 2 Tympanic Thermometer Official notice ↗
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated…
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Cardinal Health 200, LLC medical device recall: Monoject Standard Hypodermic Needle Official notice ↗
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
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Cardinal Health 200, LLC medical device recall: ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage:… Official notice ↗
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
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Cardinal Health 200, LLC medical device recall: Curity All Purpose Sponges Official notice ↗
Curity All Purpose Sponges were not sterilized and distributed
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Cardinal Health 200, LLC medical device recall: Protexis Neoprene Surgical Glove Official notice ↗
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the…
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Cardinal Health 200, LLC medical device recall: Presource PBDS Official notice ↗
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
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Cardinal Health 200, LLC medical device recall: Hydroline Trumpet Valve with Pulse Wave Cassette Official notice ↗
The suction valve may not close properly which could cause continuous suction.
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Cardinal Health 200, LLC medical device recall: Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner Official notice ↗
products may be missing a one-way valve on the fluid patient port.
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Cardinal Health 200, LLC medical device recall: Presource(R) Kits Official notice ↗
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose…
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Cardinal Health 200, LLC medical device recall: Convertors Robotic Drape with Attached Leggings Official notice ↗
Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
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Cardinal Health 200, LLC medical device recall: Converters(R) Under Buttocks Drape with Fluid Control Pouch II Official notice ↗
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
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Cardinal Health 200, LLC medical device recall: Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain Official notice ↗
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of…
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Cardinal Health 200, LLC medical device recall: V. Mueller Neuro/Spine Official notice ↗
Potential risk associated with corrosion demonstrated on the distraction screw surface.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.