Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss
American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.
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 is a Class II medical device recall without reported illnesses or injuries. The hazard is theoretical—components may have lost functionality, efficacy, or accumulated elevated residuals due to unvalidated sterilization exposure—but no confirmed harm has been reported. Per the rubric, a risk-of-harm product (obstetrical kits) where injury has not yet been reported receives a score of 3.
Plain-English summary
American Contract Systems, Inc. is recalling custom procedural convenience kits and trays designed for obstetrical and gynecological use, specifically Labor and Delivery Packs (kit numbers HILD52F and HILD52G). The recall affects 114 units distributed nationwide.
During an internal investigation, the manufacturer identified that certain components were subjected to their sterilization process without proper validation. Supporting documentation was not available to confirm these components were suitable for exposure to elevated temperatures and the sterilization procedure. As a result, the components may have lost functionality, reduced efficacy, or accumulated higher than specified residual levels from the sterilization process.
These medical devices are used in labor and delivery procedures where loss of functionality or efficacy could affect patient care. The manufacturer has not reported any confirmed incidents of harm or injury related to this issue.
Affected lot numbers are: HILD52F (lots 846221, 807221, 959231) and HILD52G (lot 885231). Consumers or healthcare providers with these products should contact the manufacturer or refer to the FDA website for guidance on next steps.
The recalled product
- Product
- Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 114
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 (11)
- a) HILD52F
- UDI/DI none
- Lot Numbers: 846221
- exp. 6/3/2023
- 807221
- exp. 7/12/2023
- 959231
- exp. 11/30/2023
- b) HILD52G
- Lot Numbers: 885231
- exp. 4/25/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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.
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