ENT Surgical Packs Recalled Due to Sterilization Validation Failure
American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.
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: The recall is classified as High severity because it involves a risk-of-harm product—surgical packs that may not be properly sterilized—without any reported injuries or illnesses to date. The sterilization validation failure poses a potential contamination risk to patients undergoing surgical procedures.
Plain-English summary
American Contract Systems, Inc. is recalling various ENT (ear, nose, and throat) surgical packs that were distributed to healthcare facilities and medical distributors throughout the United States. The recall affects three specific packs identified by their tray numbers, sterilization lot numbers, and bag serial numbers.
The products are being recalled because they were exposed to multiple sterilization cycles without proper validation for repeated exposures. The sterilization process failure may affect the sterility assurance of the affected packs, potentially compromising their safety for use in surgical procedures.
The recalled packs were distributed to healthcare systems and distributors in 13 states: Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
Healthcare facilities and practitioners who have received these packs should verify their inventory against the provided lot and serial numbers. Those with affected packs should contact American Contract Systems, Inc. for guidance regarding the recall and any required actions.
The recalled product
- Product
- Various ENT Packs
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-failure
- contamination
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 (13)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LSRHPENTLHA
- 2106181
- 838211
- 14882942 2) MREN03G
- 2104262
- 887211
- 14934943 3) COEN27K
- 2108102
- 779211
- 15093749-004
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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