Hysterectomy and Vaginal Packs Recalled for Improper Sterilization Validation
American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is that improper sterilization validation could compromise device sterility and integrity, representing a risk-of-harm to surgical patients, though no actual harm has been documented.
Plain-English summary
American Contract Systems, Inc. is recalling 29 hysterectomy and vaginal packs because the products were exposed to multiple sterilization cycles without validation. The FDA classified this as a Class II recall.
The affected packs were distributed to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas. Specific lot numbers and serial numbers have been identified by the FDA.
Improper sterilization validation could compromise the sterility and integrity of these medical devices, which are used in surgical procedures. Healthcare providers with these products should refer to the FDA recall notice for guidance on proper handling and next steps.
The recalled product
- Product
- Various hysterectomy, vaginal packs
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- improper-sterilization
- contamination-risk
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) LSRGYOSCOPYG
- 2104281
- 888211
- 63995389 2) LSRLMGLAPF
- 2105282
- 856211
- 44252282 3) LSRHPGYND
- 2106092
- 847211
- 14887375 4) LSRHPGYND
- 14887374 5) LSRHPGYND
- 14887373 6) AMJL22Z
- 2106112
- 840211
- 64176443 7) FDMN88N
- 2107013
- 821211
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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