NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, 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 #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); Firm on 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 Corporation, McGaw Park, IL 60085-6787 USA''
FDA Recall Z-0244-04 · Posted 2003-12-18
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Recalling FirmWelch Allyn Inc
Recall StatusTerminated
Product CodeDXQ
Date Initiated2003-10-27
Date Terminated2005-09-01
Product Quantity26190
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.
Firm Action
Letters dated October 27, 2003 to wholesalers/ distributors with instructions to remove/return product and notify end users.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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