FDA Medical Device Recalls (openFDA)
Welch Allyn Inc: NEONATE 1 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 #s 5082-101-2, 5082-101-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #s 30502-110 and 30502-210 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #s 5084-101-2 and 633-5084-101-2 - Arden, Skaneateles, NY.
- Recall number
- Z-0749-04
- Recalling firm
- Welch Allyn Inc
- Product
- NEONATE 1 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 #s 5082-101-2, 5082-101-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #s 30502-110 and 30502-210 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #s 5084-101-2 and 633-5084-101-2 - Arden, Skaneateles, NY.
- Status
- Terminated
- Initiated
- 2004-03-01
- Posted
- 2004-07-20
- Terminated
- 2005-09-01
- Reason
- GMP deficiencies
- Root cause
- Other
- Action
- Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
- Quantity
- not on file
- Distribution
- Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.
- Lot, serial or model codes
- Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DXQ
- Firm FEI
- 1316463
- Firm city
- Skaneateles Falls
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28