Stradis Healthcare Safety Pins Recalled for Potential Sterility Breach
Stradis Healthcare is recalling 1-inch safety pins due to manufacturing defects that may result in incomplete sealing of outer bags, potentially compromising the sterility of medical and surgical procedure kits.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential breach of sterility due to incomplete outer bag sealing, which could expose patients to contamination during medical procedures, but no actual cases of harm have been documented.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE SAFETY PINS, SMALL 1" (Item No. 515-001) due to manufacturing defects. During production, the outer bags containing these pins may not have been completely sealed, potentially resulting in a breach of sterility in the medical and surgical procedure kits.
The affected product is identified by UDI/DI M7525150011 and Lot Number 22258491483. The product was distributed nationwide in the United States and in Canada.
The recalled product
- Product
- STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 100
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 (3)
- UDI/DI (case) M7525150011
- UDI/DI (kit)M7525150011
- Serial/Lot Numbers: 22258491483
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba 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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