Kerlix Gauze Roll recall: Sterility Concern
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for…
Why was Kerlix Gauze Roll recalled?
Potential for product sterility breach due to a compromised or pinched seal defect
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?
Lot Numbers: 18E030462,18E223262,18F122962
- Product
- Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for…
- Recalling firm
- COVIDIEN LLC
- Quantity
- 2,730,821 units in total
- Distribution
- US Nationwide Distribution
- Recall date
- October 10, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)