Integra LifeSciences Corp. Recall 87596
Description: CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524
Integra LifeSciences Corp. Recall 87596 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1354-2021 |
| Event ID | 87596 |
| Event Description | CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524 |
| Product Type | Devices |
| Distribution | CA CO FL KY MD NC NC NY NY TX WI |
| Quantity | 49 units |
| Recall Reason | Incorrect labeling, Catheter did not have the required holes and markings |
| Device Classification | 20210414 |
| Device Code Info | Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205 |
| Center Classification Date | 20210405 |
| Recall Initiation Date | 20210317 |
| Recalling Firm | Integra LifeSciences Corp. |
| Initial Notification | Letter |
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