Recall Z-1344-2025— American Contract Systems Inc
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems Inc, initiated 2025-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02. Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment..
- Recalling firm
- American Contract Systems Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-06
- Firm location
- Tiffin, OH, United States
Product description
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Reason for recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.