Stradis Healthcare Cotton Applicator 3 inch kits recalled due to incomplete bag sealing
Stradis Healthcare is recalling cotton applicator 3 inch kits used in medical and surgical procedures due to incomplete outer bag sealing that may compromise kit sterility. Kits were distributed nationwide in the U.S. and Canada.
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 medical device with a sterility defect that poses a risk of infection in medical procedures, but no illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling cotton applicator 3 inch kits (Item No. 505-010) distributed nationwide in the United States and Canada. These kits are used in medical and surgical procedures.
The recall was issued because the kits underwent manufacturing conditions that may have resulted in the outer bag being incompletely sealed. An incomplete seal may allow a breach in the sterility of the kit, which is essential for safe medical and surgical use.
Affected lots include Serial/Lot Numbers 22269491064, with UDI/DI (case) M7525050101 and UDI/DI (kit) M7525050100. Healthcare facilities and medical professionals who have these kits should cease use and contact the manufacturer for instructions or replacement.
The recalled product
- Product
- STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- incomplete-seal
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) M7525050101
- UDI/DI (kit)M7525050100
- Serial/Lot Numbers: 22269491064
Distribution
Distributed nationwide across the United States.
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