Z-0757-04

NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only...

Name: Z-0757-04 NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only...
Creator: Welch Allyn Inc
Published: 2004-03-01
License: https://open.fda.gov/license/

Welch Allyn Inc / initiated 2004-03-01 / Terminated

FDA source

Welch Allyn Inc began a recall of NEONATE 5 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... on 2004-03-01. The reason FDA records is "GMP deficiencies". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0757-04
Status: Terminated
Initiated: 2004-03-01
Posted: 2004-07-20
Terminated: 2005-09-01
Recalling firm: Welch Allyn Inc
Product: NEONATE 5 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 # 5082-105-2, 5082-105-2CL, 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 # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY.
Product code: DXQ Blood Pressure Cuff
Reason for recall: GMP deficiencies
FDA root cause: Other
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.
Product codes and lots: Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Product code DXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)