Lamicel 20PK 5MM INTL recall: Sterility Concern
Lamicel 20PK 5MM INTL
Why was Lamicel 20PK 5MM INTL recalled?
Routine sterilization dose does not meet the required Sterility Assurance Level.
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: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918
- Product
- Lamicel 20PK 5MM INTL
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 307 packs; 6140 units
- Distribution
- Affected product was only distributed in Japan.
- Recall date
- January 1, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)