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U.S. Department of Health and Human Services

Class 3 Device Recall FLAT DRAIN 10MM, CHARIKERJETER DRESSING KITS (LARGE AND SMALL)

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  Class 3 Device Recall FLAT DRAIN 10MM, CHARIKERJETER DRESSING KITS (LARGE AND SMALL) see related information
Date Initiated by Firm March 31, 2008
Date Posted August 06, 2008
Recall Status1 Terminated 3 on November 18, 2008
Recall Number Z-1620-2008
Recall Event ID 47521
510(K)Number K042134  
Product Classification Pump, portable, aspiration (manual or powered) - Product Code BTA
Product FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product.
Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.
Code Information Lot numbers: 517141, 517269, 517143, and 517108
Recalling Firm/
Manufacturer		 Smith And Nephew, Inc. Wound Management Division
11775 Starkey Road
Largo FL 33773-4727
For Additional Information Contact
727-399-3785
Manufacturer Reason
for Recall		 Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.
FDA Determined
Cause 2		 Labeling mix-ups
Action Consignees were notified of recall by letter (Correction and Removal Notification) sent to customers on 3/31/08. They were asked to check their stocks, identify, and return all affected units to Smith & Nephew according to the instructions. Consignees are to contact the Customer Care Center at 1-800-876-1261, if they have additional questions.
Quantity in Commerce 4796
Distribution Nationwide Distribution.
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 = BTA and Original Applicant = BLUE SKY MEDICAL GROUP INCORPORATED
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