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U.S. Department of Health and Human Services

Class 3 Device Recall PROTOCOL Blood Pressure Cuff

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  Class 3 Device Recall PROTOCOL Blood Pressure Cuff see related information
Date Initiated by Firm March 07, 2001
Date Posted October 15, 2003
Recall Status1 Terminated 3 on April 15, 2008
Recall Number Z-1237-03
Recall Event ID 26287
Product Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00 PROTOCOL SYSTEMS, INC. Beaverton, OR 97008-7107 USA Assembled in Mexico***.'
Code Information Lot 0601
Recalling Firm/
Manufacturer		 GE Medical Systems Information Technologies
4502 Woodland Corporate Blvd.
Tampa FL 33614
For Additional Information Contact Thomas English
813-887-2000
Manufacturer Reason
for Recall		 Wrong connector attached to blood pressure cuff.
FDA Determined
Cause 2		 Other
Action The recalling firm telephoned the one account involved on 3/7/2001 and also mailed a Recall Notification letter to the firm on 3/7/2001 requesting return of the product.
Quantity in Commerce 100 cuffs
Distribution Product was distributed to one distributor in Oregon.
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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