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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 01, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 01, 2005
Recall Number Z-0749-04
Recall Event ID 28428
Product Classification Blood Pressure Cuff - Product Code DXQ
Product NEONATE 1 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 #s 5082-101-2, 5082-101-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #s 30502-110 and 30502-210 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #s 5084-101-2 and 633-5084-101-2 - Arden, Skaneateles, NY.
Code Information Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)
Recalling Firm/
Welch Allyn Inc
4341 State Street Rd
Skaneateles Falls NY 13153-5300
For Additional Information Contact John Sawyer
Manufacturer Reason
for Recall
GMP deficiencies
FDA Determined
Cause 2
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.