Class 2 Device Recall

• Date Initiated by Firm: March 01, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 01, 2005
• Recall Number: Z-0757-04
• Recall Event ID: 28428
• Product Classification: Blood Pressure Cuff - Product Code DXQ
• Product: NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY.
• Code Information: Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)
• Recalling Firm/ Manufacturer: Welch Allyn Inc; 4341 State Street Rd; Skaneateles Falls NY 13153-5300
• For Additional Information Contact: John Sawyer; 315-685-4571
• Manufacturer Reason for Recall: GMP deficiencies
• FDA Determined Cause: Other
• Action: Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
• Distribution: Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.
• 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.