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U.S. Department of Health and Human Services

Class 2 Device Recall Platelet Concentrator

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 Class 2 Recall
Platelet Concentrator
see related information
Date Posted September 20, 2008
Recall Status1 Terminated on May 28, 2010
Recall Number Z-2446-2008
Recall Event ID 49129
Premarket Notification
510(K) Number
K041976 
Product Classification Syringe, Piston - Product Code FMF
Product Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116.
Code Information Lot Nos.: 07EQT0003, 07EQT0004, 07EQT0005, 07JQT0003, 07KQT0002, 63207107, 07HM12429, and 07JM15582.
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E Brooks Rd
Memphis, Tennessee 38116-1804
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall
Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Prior to the dissemination of the official notices, the firm notified personnel at our field offices of the BD syringe recall and advised that a subsequent recall of our Caption devices would follow. High volume users were contacted via phone on July 30th and the 31st and personnel at all affected field offices were notified via email on July 30, 2008 with an Urgent Medical Device Recall Letter. The firm requedsted that usere immediately cease distribution, examin the stock on hand and the stock of the accounts that have been suppplied and remove any affected ecices from all inventory. A verification notification was included with letter.
Quantity in Commerce 364 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = SMITH & NEPHEW, INC.
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