Surgical room recall: Sterility Concern
Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
Why was Surgical room recalled?
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI (case) M75241236SDSP1, UDI/DI (kit)M75241236SDSP0, Serial/Lot Numbers: 22235489632
- Product
- Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Quantity
- 20 units
- Distribution
- US nationwide distribution, and Canada.
- Recall date
- December 21, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)