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Terminated

NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-1 - Arden, Skaneateles, NY.

FDA Recall Z-0752-04 · Posted 2004-07-20

Recalling FirmWelch Allyn Inc
Recall StatusTerminated
Product CodeDXQ
Date Initiated2004-03-01
Date Terminated2005-09-01

Reason for Recall

GMP deficiencies

Firm Action

Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.

Root Cause

Other

Distribution Pattern

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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