Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA
FDA device recall Z-1233-2017 · posted 2017-02-22 · Terminated
Recall details
- Recalling firm
- Degania Silicone, Ltd.
- Reason for recall
- Product sterility compromised due to breach of sterile barrier
- Action taken
- Degania Silicone Ltd. issued an Urgent Recall letter dated 1/31/17 and requested return of the product to Degania Silicone 14 Thurber Boulevard, Suite A, Smithfield, RI 02917, USA.. For questions regarding this recall call +1-401-349-5373.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GBX
- Quantity affected
- 3040 units
- Distribution
- To PR only
- Date initiated
- 2017-01-31
- Date posted
- 2017-02-22
- Date terminated
- 2017-04-04
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