Caesarean section packs recalled after being sterilized more than once
American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
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: Scored 3 under the risk-of-harm criterion: quality and safety cannot be confirmed for kits used in invasive procedures, and no injuries are reported.
Plain-English summary
Medical convenience kits used in caesarean sections are being recalled, covering item numbers FHCP08Y (C Section Pack), HICS50I (C-Section Pack) and HSCB90B (C-Section Basin Pack).
The identified products were re-gassed, meaning sterilized more than once, after a nonconformance occurred during the initial ethylene oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so product quality, safety and effectiveness cannot be confirmed.
The action covers 32,433 units in total across the firm's affected kits, distributed in South Dakota, Iowa, Minnesota, Washington and Illinois. The FDA has classified the action as Class II.
Facilities should identify affected item, lot and bag serial numbers, quarantine them and follow the firm's instructions.
The recalled product
- Product
- Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Surgical kit
- Hazard
- resterilization
- unvalidated-process
- sterility-assurance
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 (3)
- FHCP08Y UDI-DI 191072232724 Lot 8216211 Bag serial number 68258296
- HICS50I UDI-DI 191072212351 Lot 8161711 Bag serial number 68273637
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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