American Contract Systems, Inc. recalls
24 recalls in our records from 2018 to 2026: 24 FDA medical devices.
Recalls with full detail pages
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American Contract Systems Inc medical device recall: Convenience kits containing Medline Namic Angiographic Control…
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full…
Earlier and other recalls
These link to the official agency notice.
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American Contract Systems Inc medical device recall: Medical convenience kits containing BD CliniClean Pericare Wipes… Official notice ↗
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing…
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American Contract Systems Inc medical device recall: American Contract System Convenience Kit Official notice ↗
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified…
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American Contract Systems Inc medical device recall: American Contract Systems medical procedure kits and trays labeled… Official notice ↗
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models…
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American Contract Systems Inc. medical device recall: Basic Biopsy Tray Official notice ↗
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These…
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American Contract Systems Inc medical device recall: American Contract Systems Official notice ↗
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit…
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American Contract Systems, Inc. medical device recall: Lower Extremity Official notice ↗
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may…
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American Contract Systems, Inc. medical device recall: Brand Name: Banner Health Systems Product Name: Cysto Pack… Official notice ↗
Sterility assurance with procedure trays
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American Contract Systems Inc medical device recall: Laparoscopy Pack Official notice ↗
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
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American Contract Systems Inc medical device recall: Crani Pack Official notice ↗
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for…
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American Contract Systems, Inc. medical device recall: Pacemaker Pack Official notice ↗
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is…
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American Contract Systems, Inc. medical device recall: American Contract Systems Hand Pack convenience kit Official notice ↗
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in…
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American Contract Systems Inc medical device recall: AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog… Official notice ↗
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by…
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American Contract Systems, Inc. medical device recall: Custom procedural convenience kits and trays Official notice ↗
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no…
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American Contract Systems, Inc. medical device recall: General Pack Official notice ↗
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently…
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American Contract Systems, Inc. medical device recall: Total Knee Pack Official notice ↗
Incorrect expiration date on product.
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American Contract Systems, Inc. medical device recall: Basin Set Official notice ↗
Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
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American Contract Systems, Inc. medical device recall: COVID Test Kit Nonsterile Official notice ↗
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
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American Contract Systems, Inc. medical device recall: Various Angiography packs/trays Official notice ↗
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
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American Contract Systems, Inc. medical device recall: Clean Catch Urine Kit NS 178489 Official notice ↗
Affected products were assembled off-site by individuals who may not have been properly trained.
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American Contract Systems, Inc. medical device recall: 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray Official notice ↗
Product was sterilized with a higher than specification EO concentration.
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American Contract Systems medical device recall: Sterile Custom Packs to be used in surgical procedures Official notice ↗
The surgical gowns were manufactured in a facility that is not registered by the FDA.
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American Contract Systems, Inc. medical device recall: Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits… Official notice ↗
Potential that product has not reached complete sterilization,
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American Contract Systems, Inc. medical device recall: Powdered Surgical Gloves Official notice ↗
Powdered Surgical Gloves are an FDA banned substance.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.