Lamicel 20PK 3MM INTL Cervical dilator recall: Sterility Concern
Lamicel 20PK 3MM INTL Cervical dilator
Why was Lamicel 20PK 3MM INTL Cervical dilator 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: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438
- Product
- Lamicel 20PK 3MM INTL Cervical dilator
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 29320 units
- Distribution
- Affected product was only distributed in Japan.
- Recall date
- January 1, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)