Medical device convenience packs exposed to unvalidated sterilization cycles
American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving potential sterility assurance compromise from unvalidated sterilization exposure. No reported illnesses, injuries, or hospitalizations. Classified as risk-of-harm product without reported injury, warranting High severity.
Plain-English summary
American Contract Systems, Inc. is recalling 116 convenience packs that were distributed to health systems and distributors across 13 states: Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
The packs were exposed to multiple sterilization cycles without validation for multiple exposures. This unvalidated reprocessing may compromise the sterility assurance of the devices, potentially affecting their safety and effectiveness.
Health systems and distributors who received affected convenience packs should stop using them and contact American Contract Systems, Inc. for guidance on return or replacement. Facilities should verify whether they have received any of the affected lot numbers listed in the recall notice.
The recalled product
- Product
- Various convenience packs
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterility-assurance-compromise
- sterilization-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LSRICUMXBARB
- 2104091
- 905211
- 14531603 2) LSRBASICPACD
- 90921+A3:A1061
- 14798924 3) LSRCFBVIIIPKE
- 904211
- 14806477 4) LSRBASICPACD
- 2105101
- 881211
- 14880418 5) LSRMAJBASINC
- 2106082
- 860211
- 44252207 6) LSRMAJBASINC
- 44251930 7) LSRLATEXTUBA
- 2106021
- 855211
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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