Lamicel 20PK 3MM INTL Cervical dilator
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-0733-2020
- Quantity
- 29320 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: 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
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.