Class 3 Device Recall PROTOCOL Blood Pressure Cuff

• Date Initiated by Firm: March 07, 2001
• Date Posted: October 15, 2003
• Recall Status: Terminated 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: 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.