—#216284

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

FDA product code: MLS — Labor And Delivery Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / 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

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.

Recalling firm

Firm: American Contract Systems Inc.
Address: 1601 Se Gateway Dr, Ste 120, Grimes, Iowa 50111-5223

Distribution

Distribution pattern: US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Timeline

Recall initiated: 2025-09-04
Posted by FDA: 2025-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216284. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.