PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
Stradis Healthcare recalls PHS Lacertaion Tray sterile surgical kits due to potential pinhole leaks in outer packaging near the seal that could compromise sterility. 300 units affected across 10 US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 theoretical risk of sterility breach due to potential packaging seal failure; the source reports no illnesses or injuries, and the hazard is potential rather than confirmed, qualifying as at most High per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Stradis Healthcare is recalling PHS Lacertaion Tray sterile surgical kits (300 units) manufactured for Professional Hospital Supply, Inc. The product is a sterile surgical tray distributed nationwide.
The recall was initiated because the outer packaging bag may develop pinhole leaks near the seal, which could result in a breach of the kit's sterility. Such leaks in sterile medical device packaging can allow microbial contamination.
Affected products include Assembly Number 477944 (UDI-DI: M7524779441) with lot numbers 220974270 and 220915145. Distribution was nationwide across Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.
Healthcare facilities that received affected lots should stop use immediately and contact Stradis Healthcare for replacement or return instructions. No illnesses or injuries have been reported associated with this recall.
The recalled product
- Product
- PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
- Manufacturer
- Stradis Healthcare
- Affected units
- 300
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 (4)
- Assembly Number 477944
- UDI-DI: M7524779441
- Lot Numbers: 220974270
- 220915145
Distribution
Part of a larger recall action
This product is one of 18 recalled by Stradis Healthcare 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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