Medical convenience kits recall
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY…
Why was Medical convenience kits 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY…
- Recalling firm
- American Contract Systems Inc.
- Quantity
- 32,433 total
- Distribution
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Recall date
- October 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)