Recall Z-0932-2023— Stradis Healthcare
Class II · Ongoing
Class II FDA medical device recall by Stradis Healthcare, initiated 2022-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.. Reason: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit..
- Recalling firm
- Stradis Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-15
- Firm location
- Waukegan, IL, United States
Product description
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Reason for recall
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.