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U.S. Department of Health and Human Services

Class 2 Device Recall American Contract Systems

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 Class 2 Device Recall American Contract Systemssee related information
Date Initiated by FirmSeptember 04, 2025
Date PostedOctober 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0173-2026
Recall Event ID 97659
Product Classification Labor and Delivery Kit - Product Code MLS
ProductMedical 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
Code Information 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
FEI Number 3007069947
Recalling Firm/
Manufacturer		 American Contract Systems Inc.
1601 Se Gateway Dr Ste 120
Grimes IA 50111-5223
For Additional Information ContactMarlene Jones
470-280-4277
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionFirm 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.
Quantity in Commerce32,433 total
DistributionUS Nationwide distribution in the states of SD, IA, MN, WA, IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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