C-Section Surgical Packs recalled for improper sterilization validation
American Contract Systems recalls C-section surgical packs that were exposed to multiple sterilization cycles without validation. The sterilization integrity of the 24 affected units cannot be assured.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is a sterilization validation deficiency that could affect sterile integrity of surgical instruments used in patient procedures. Without reported harm, the severity is capped at High per the rubric.
Plain-English summary
American Contract Systems, Inc. is recalling various C-section surgical packs. The affected units were subjected to multiple sterilization cycles without validation that the products could withstand repeated sterilization exposures.
Proper sterilization and sterilization validation are critical to ensure that surgical instruments can be safely used in patient care procedures. Without validation for multiple sterilization cycles, the integrity of the sterilization process cannot be guaranteed, raising the potential risk that instruments may not be adequately sterilized before use.
The affected packs—24 units—were distributed to health systems and medical device distributors in 13 states: Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
Healthcare facilities that received products from the identified lots should contact American Contract Systems, Inc. for information and instructions regarding the recall.
The recalled product
- Product
- Various C-section packs
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Packs
- Hazard
- sterile-integrity
- reprocessing-validation
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) LSRHPCSECTB
- 2106301
- 826211
- 64124711 2) FHCP08U
- 2107143
- 807211
- 64166455 3) LMSE38N
- 2108202
- 770211
- 64231900 4) CFCS39G
- 2108243
- 768211
- 64232041 5) IHCS29AA
- 2109272
- 733211
- 64214921 6) CXCS92U
- 2106191
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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