HIGH

American Contract Systems Labor Delivery Packs Recalled for Re-Gassed Sterilization Flaw (2025)

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

Quick Facts at a Glance

Recall Date
September 4, 2025
Hazard Level
HIGH
Brand
American Contract Systems
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

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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About This Product

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.

Why This Is Dangerous

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.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

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.

Practical Guidance

How to identify if yours is affected

  1. Identify model numbers AHLD15X, AKDV96B, EVBH28D, UPVD01K on the packaging and labels
  2. Check UDIs and Lot numbers: AHLD15X 191072224767 Lot 8188711; AKDV96B 191072224019 Lot 7311311; EVBH28D 191072239051 Lot 8424611; UPVD01K 191072238993 Lot 8439111
  3. Compare with the recall notice for confirmation

Where to find product info

Recall letter from American Contract Systems and FDA recall page under Z-0173-2026

What timeline to expect

Refund or replacement processing typically 4-6 weeks after verification of eligibility

If the manufacturer is unresponsive

  • File a consumer complaint with the FDA/CBSA if applicable
  • Ask hospital procurement for assistance and escalation to manufacturer

How to prevent similar issues

  • Only rely on sterilization processes validated by EO gas suppliers
  • Source sterile packs from reputable manufacturers
  • Maintain clear records of lot and serial numbers for recall notices

Documentation advice

Keep the recall letter, take photos of labels and packaging, record model/UDI/Lot numbers, save all correspondence with supplier

Product Details

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

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 32,433 total units recalled
  • 4 models affected: AHLD15X, AKDV96B, EVBH28D, UPVD01K
  • Models list with UDI-DI and Lot numbers provided
  • EO gas re-gassing identified as root issue
  • US nationwide distribution with state mentions SD, IA, MN, WA, IL
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeLabor Delivery Pack / Birthing Room Pack
Sold At
Unknown

Product Details

Model Numbers
AHLD15X UDI-DI 191072224767 Lot 8188711
AKDV96B UDI-DI 191072224019 Lot 7311311
EVBH28D UDI-DI 191072239051 Lot 8424611
UPVD01K UDI-DI 191072238993 Lot 8439111
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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