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U.S. Department of Health and Human Services

Class 2 Device Recall Jejunal Feeding Set

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  Class 2 Device Recall Jejunal Feeding Set see related information
Date Initiated by Firm July 24, 2009
Date Posted September 01, 2009
Recall Status1 Terminated 3 on April 06, 2010
Recall Number Z-1910-2009
Recall Event ID 52758
510(K)Number K920703  
Product Classification Gastrointestinal Tubes and Accessories - Product Code KNT
Product Jejunal Feeding Set, Product Order number FLOWJ-9-20.

This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support.
Code Information Lot number W2676476
Recalling Firm/
Manufacturer		 Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Sharon Miles
336-744-0157
Manufacturer Reason
for Recall		 The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
FDA Determined
Cause 2		 Process control
Action The consignee was notified by an Urgent: Field Safety Notice, dated 07/24/2009. The distributor (Cook Ireland) was instructed to contact the Italian Company Representative. The appropriate Patient Care Manual with the Italian translation was provided to the medical facility with the assistance of the Area Representative. The Area Representative instructed the medical facility staff to provide the translated Patient Care Manual to the caregiver(s) of the patient that received the Jejunal Feeding Sets. The distributor is already aware of the situation. The lower portion of the letter was to be filled out and sent to Cook Endoscopy.
Quantity in Commerce 4 units
Distribution International Only Distribution -- Country of Italy.
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.
510(K) Database 510(K)s with Product Code = KNT and Original Applicant = WILSON-COOK MEDICAL, INC.
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