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U.S. Department of Health and Human Services

Class 3 Device Recall Jackson Pratt" Channel drain

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  Class 3 Device Recall Jackson Pratt" Channel drain see related information
Date Initiated by Firm October 03, 2017
Date Posted February 20, 2018
Recall Status1 Terminated 3 on October 21, 2020
Recall Number Z-0899-2018
Recall Event ID 79199
Product Classification Catheter, irrigation - Product Code GBX
Product Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234.

Used for the drainage of body fluids for surgical use.
Code Information Lot No P1607442.
Recalling Firm/
Manufacturer		 Degania Silicone, Ltd.
Degania Bet
Dganya Bet Israel
For Additional Information Contact
401-349-5373
Manufacturer Reason
for Recall		 Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
FDA Determined
Cause 2		 Error in labeling
Action An Urgent Medical Device Correction letter, dated October 03, 2017, was sent to the customer. The letter identified the affected device and the reason for the recall. The letter instructed the consignee to check its stock in order to remove all mislabeled product from the market and eliminate potential risk of misuse. The customer was instructed to return the completed Confirmation Sheet to Degania Silicone, as well as any unlabeled product. Questions regarding the recall should be directed to Katia Kayam, Customer Complaints Officer at Katia@ds-il.com.
Quantity in Commerce 4,000 units
Distribution US Distribution to Puerto Rico.
Total Product Life Cycle TPLC 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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