Labor and Delivery System Recalled for Sterilization Assurance Issue
American Contract Systems is recalling 1,836 Labor and Delivery PPS kits due to inability to confirm sterilization requirements were met. The affected units may lose functionality, potentially delaying patient treatment.
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: FDA Class II recall with no reported injuries or illnesses. Sterilization assurance failure on labor and delivery equipment represents a confirmed risk of harm in a critical clinical setting. Per the rubric, a risk-of-harm medical device without reported injury justifies High severity.
Plain-English summary
American Contract Systems Inc is recalling 1,836 Labor and Delivery PPS kits, models LLLD64O, LLLD64O-01, and LLLD64O-02. The manufacturer was unable to confirm that product sterilization assurance requirements were met for the affected units.
Sterilization is critical for medical devices used in labor and delivery. If sterilization requirements are not met, the equipment may lose or lack functionality, which could delay or prolong patient treatment during labor and delivery.
The affected kits were distributed nationwide in Ohio. The recall involves units bearing the following lot numbers: 892241, 70-051048, 70-051516, 70-052113, 70-052313, 70-052401, and 70-052911.
The recalled product
- Product
- LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-assurance
- functionality-loss
Distribution
Distributed nationwide across the United States.
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