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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/
GE Medical Systems Information Technologies
4502 Woodland Corporate Blvd.
Tampa FL 33614
For Additional Information Contact Thomas English
Manufacturer Reason
for Recall
Wrong connector attached to blood pressure cuff.
FDA Determined
Cause 2
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.