NAMIC Convenience Kit recall: Sterility Concern
NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC…
Why was NAMIC Convenience Kit recalled?
The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lots 4361732, 4445198, 4512179, 4596980, 4608449, 4657491, 4671286, 4699834, 4742947, 4764114, 4772460, 4806954, 4812145.
- Product
- NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC…
- Recalling firm
- Navilyst Medical, Inc
- Quantity
- 20 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
- Recall date
- March 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)