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U.S. Department of Health and Human Services

Class 2 Device Recall Platelet Concentrator

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  Class 2 Device Recall Platelet Concentrator see related information
Date Initiated by Firm August 05, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on May 28, 2010
Recall Number Z-2446-2008
Recall Event ID 49129
510(K)Number K041976  
Product Classification Piston syringe - 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/
Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Victor Rocha
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
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 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 = FMF and Original Applicant = SMITH & NEPHEW, INC.