Date Initiated by Firm |
January 31, 2017 |
Date Posted |
February 22, 2017 |
Recall Status1 |
Terminated 3 on April 04, 2017 |
Recall Number |
Z-1233-2017 |
Recall Event ID |
76368 |
Product Classification |
Catheter, irrigation - Product Code GBX
|
Product |
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. |
Code Information |
Lot Number: P1546816 Expiration date: January 2021 |
Recalling Firm/ Manufacturer |
Degania Silicone, Ltd. Degania Bet Dganya Bet Israel
|
Manufacturer Reason for Recall |
Product sterility compromised due to breach of sterile barrier
|
FDA Determined Cause 2 |
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 in Commerce |
3040 units |
Distribution |
To PR only |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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