The Recall Desk
HighFDA (Devices)·Z-1701-2022·Announced 2022-09-14

Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure

American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves surgical packs with unvalidated sterilization, which poses a potential infection risk to patients. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, meeting the rubric criteria for High (Score 3) severity.

Plain-English summary

American Contract Systems is recalling certain obstetric and gynecology surgical packs (15 units total) distributed to health systems and medical device distributors in multiple U.S. states. These packs are used in surgical procedures and must maintain strict sterilization to ensure patient safety.

The recalled products were exposed to multiple sterilization cycles without validation or testing to confirm the packs remained safe and sterile after multiple exposures. This lack of validation could compromise the sterility integrity of the surgical instruments, potentially increasing infection risk for patients undergoing procedures.

The affected packs were distributed to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas. Detailed identification information including tray numbers, sterilization lots, and batch serial numbers is available in the FDA's official recall notice. No illnesses or injuries related to these packs have been reported.

Health systems and distributors who have received these packs should consult the FDA recall notice and contact American Contract Systems for guidance on product disposition and replacement.

The recalled product

Product
Various ob/gyn packs
Manufacturer
American Contract Systems, Inc.
Category
Medical Device — Obstetric/Gynecology Surgical Supplies
Hazard
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Tray Number
  • Sterilization Lot
  • Lot Number
  • Bag Serial Number 1) LSROBDELIVC
  • 2104091
  • 904211
  • 14531604 2) LSRVAGDELIVC
  • 2106011
  • 863211
  • 44252284 3) LSRVAGDELIVC
  • 44135283 4) LSRCFHVAGDC
  • 2108042
  • 791211
  • 64123598 5) LSRCFHVAGDC
  • 64123599 6) LSRCFHVAGDC
  • 64123597 7) LSRVAGDELIVC
  • 2108181
  • 776211
  • 44139780 8) LSROBDELIVC
  • 2109231

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 17 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Related recalls

Same manufacturer · American Contract Systems, Inc.

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Same hazard · unvalidated sterilization

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