Lamicel 20PK 5MM INTL
This recall is currently active, issued November 13, 2019. It was issued by Medtronic Xomed, Inc..
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- November 13, 2019
- Recall Number
- Z-0734-2020
- Quantity
- 307 packs; 6140 units
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Routine sterilization dose does not meet the required Sterility Assurance Level.
Distribution
Affected product was only distributed in Japan.
Lot / Code Info
UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918
Root Cause
Process control
Action Taken
Medtronic will send the Consignee Notification and Customer Confirmation Form (or equivalent record) to each listed consignee. Consignees will be asked to confirm receipt of FCA notification.
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