Surgical Trays Recalled Due to Incomplete Bag Sealing and Potential Loss of Sterility
Stradis Medical recalls surgical trays with incomplete outer bag seals that may breach kit sterility. No illnesses or injuries reported.
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 medical device recall. No illnesses or injuries have been reported, and the hazard is theoretical. However, compromised sterility in surgical instruments presents a significant risk of contamination during medical procedures. Per the rubric, medical devices with potential for harm but no reported illness score at 3 (High).
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling surgical procedure trays and kits (SURGICAL PACK, Item No. 40996WLS, oral surgery tray) distributed nationwide in the US and Canada.
During manufacturing, certain units received incompletely sealed outer bags, which may result in a breach of the kit's sterility. Compromised sterility in surgical instruments can allow contamination during medical procedures.
Affected units include those with UDI/DI (case) M75240996WLS1, UDI/DI (kit) M75240996WLS0, and Lot Number 22230489371. No illnesses or injuries have been reported to date.
Healthcare providers and patients who have received these kits should contact Stradis Medical for instructions on affected units. Healthcare facilities should review inventory and quarantine affected products pending further guidance.
The recalled product
- Product
- Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray
- 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) M75240996WLS1
- UDI/DI (kit)M75240996WLS0
- Serial/Lot Numbers: 22230489371
Distribution
Distributed nationwide across the United States.
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