FDA Medical Device Recalls (openFDA)
GE Medical Systems Information Technologies: Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00 PROTOCOL SYSTEMS, INC. Beaverton, OR 97008-7107 USA Assembled in Mexico***.'
- Recall number
- Z-1237-03
- Recalling firm
- GE Medical Systems Information Technologies
- Product
- Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00 PROTOCOL SYSTEMS, INC. Beaverton, OR 97008-7107 USA Assembled in Mexico***.'
- Status
- Terminated
- Initiated
- 2001-03-07
- Posted
- 2003-10-15
- Terminated
- 2008-04-15
- Reason
- Wrong connector attached to blood pressure cuff.
- Root cause
- Other
- Action
- The recalling firm telephoned the one account involved on 3/7/2001 and also mailed a Recall Notification letter to the firm on 3/7/2001 requesting return of the product.
- Quantity
- 100 cuffs
- Distribution
- Product was distributed to one distributor in Oregon.
- Lot, serial or model codes
- Lot 0601
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1030184
- Firm city
- Tampa
- Firm state
- FL
- 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