Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

NEONATE 4 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 # 5082-104-2, 5082-104-2CL, 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 # 30502-113 and 30502-213 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-2 and 636-5084-104-2 - Arden, Skaneateles, NY.

FDA Recall Z-0755-04 · 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.

↑