FDA Recall
Terminated
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.
Recall: Z-1233-2017
·
Initiated January 31, 2017
Recall
- Recall Number
- Z-1233-2017
- Event Number
- 76368
- Firm
- Degania Silicone, Ltd. Degania Bet Dganya Bet Israel
- FEI Number
- 7682
- Product Code
- GBX
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- January 31, 2017
- Posted
- February 22, 2017
- Terminated
- April 4, 2017
Description
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.
Reason
Product sterility compromised due to breach of sterile barrier
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.
Distribution
To PR only
Quantity
3040 units