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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 October 27, 2003
Date Posted December 18, 2003
Recall Status1 Terminated 3 on September 01, 2005
Recall Number Z-0245-05
Recall Event ID 27522
Product Classification Blood Pressure Cuff - Product Code DXQ
Product NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows:

Welch Allyn Tycos #5082-104-2 (10 pack/2 tubes);
Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp);
Welch Allyn Tycos #5082-241-10 (5 pack/2 tubes, multi-size pack);
Allegiance Tactics #30502-113 (case of 40/2 tubes);
Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp);
Welch Allyn Tycos/Allegiance #5082-241-16

Firm on the label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corp., McGaw Park, IL 60085-6787 USA''.
Code Information Code dates between June 20, 2003 and October 8, 2003. (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
Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.
FDA Determined
Cause 2
Action Letters dated October 27, 2003 to wholesalers/ distributors with instructions to remove/return product and notify end users.
Quantity in Commerce 26190
Distribution The product was sold thru 11 distributors. The product was shipped to end users nationwide. There is one foreign distributor in Singapore. In addition, Welch Allyn shipped product to their affiliates in Ireland, Australia, and South Africa.
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.