American Contract Systems Inc.: Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGIN
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- American Contract Systems Inc.
- Product
- Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK
- Reason / hazard
- Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Recall initiated
- 2025-09-04
- Code info
- AHLD15X UDI-DI 191072224767 Lot 8188711 Bag serial no. 17555039 17555044 17555049 17609166 17609181; AKDV96B UDI-DI 191072224019 Lot 7311311 Bag serial no. 47140875 47141919; EVBH28D UDI-DI 191072239051 Lot 8424611 Bag serial no. 17754395; UPVD01K UDI-DI 191072238993 Lot 8439111 Bag serial no. 17682598 Log 8499211 Bag serial no. 17742543
- Product quantity
- 32,433 total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Grimes
- State
- IA
- Country
- United States
- Event id
- 97659
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