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U.S. Department of Health and Human Services

Class 2 Device Recall Otocell Ear Wick

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  Class 2 Device Recall Otocell Ear Wick see related information
Date Initiated by Firm January 22, 2003
Date Posted February 21, 2003
Recall Status1 Terminated 3 on October 05, 2007
Recall Number Z-0561-03
Recall Event ID 25435
510(K)Number K972581  
Product Boston Medical Products Otocell Ear Wick 15 mm, sterile
Ref: EW-0915
Code Information Lot Number: 56003 Exp.Date: 7/2005
Recalling Firm/
Manufacturer		 Boston Medical Products, Inc.
117 Flanders Rd
Westborough MA 01581-1042
For Additional Information Contact Michael A. Warren
508-898-9300 Ext. 228
Manufacturer Reason
for Recall		 Product sterility may be compromised
FDA Determined
Cause 2		 Other
Action Boston Medical Products notified their accounts by letter on 1/22/03. Users are requested to discard product and complete reply form.
Quantity in Commerce 267 units
Distribution Nationwide
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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