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U.S. Department of Health and Human Services

Class 2 Device Recall Jackson Pratt" Channel drain

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 Class 2 Device Recall Jackson Pratt" Channel drainsee related information
Date Initiated by FirmJanuary 31, 2017
Date PostedFebruary 22, 2017
Recall Status1 Terminated 3 on April 04, 2017
Recall NumberZ-1233-2017
Recall Event ID 76368
Product Classification Catheter, irrigation - Product Code GBX
ProductJackson-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
FEI Number 7682
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
ActionDegania 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 Commerce3040 units
DistributionTo PR only
Total Product Life CycleTPLC Device Report
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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