Recall Z-1233-2017 ยท GBX Catheter, Irrigation
Degania Silicone, Ltd.
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
| Date | Feb 22, 2017 (initiated Jan 31, 2017) |
| Status | Terminated |
| Reason | Product sterility compromised due to breach of sterile barrier |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 3040 units |
| Distribution | To PR only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.