American Contract Systems recalled 32,433 labor and delivery packs nationwide in the United States, including the states of South Dakota, Iowa, Minnesota, Washington and Illinois. Re-gassing occurred after a nonconformance in the Ethylene Oxide gas injection process. The affected packs have not been validated for exposure to multiple sterilization cycles. Hospitals and health systems should stop使用
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
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Labor and delivery packs are bundled sterile supplies used during childbirth in hospital settings. They include items needed for vaginal delivery and birthing room procedures. Hospitals rely on validated sterilization to ensure patient safety.
The key issue is re-gassing after a nonconformance in EO sterilization. The packs have not been validated for exposure to multiple sterilization cycles, which could compromise sterility and effectiveness.
This recall is not described as part of a broader industry pattern.
Hospitals may need to replace affected packs and may experience temporary disruption in stock. The recall could affect patient safety if sterility is not guaranteed.
Recall letter from American Contract Systems and FDA recall page under Z-0173-2026
Refund or replacement processing typically 4-6 weeks after verification of eligibility
Keep the recall letter, take photos of labels and packaging, record model/UDI/Lot numbers, save all correspondence with supplier
Brand: American Contract Systems. Affected products include AHLD15X Labor Delivery Pack (213387), AKDV96B Vaginal Delivery, EVBH28D Birthing Room Pack, UPVD01K Vaginal Delivery Pack. Each model lists a UDI-DI and Lot number: - AHLD15X UDI-DI 191072224767 Lot 8188711 - AKDV96B UDI-DI 191072224019 Lot 7311311 - EVBH28D UDI-DI 191072239051 Lot 8424611 - UPVD01K UDI-DI 191072238993 Lot 8439111 Distribution: US nationwide, including SD, IA, MN, WA, IL Quantity: 32,433 units Sold/Price: Not disclosed Country of origin: Unknown
No injuries or incidents have been reported.
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