FDA Recall
Terminated
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: Z-1237-03
·
Initiated March 7, 2001
Recall
- Recall Number
- Z-1237-03
- Event Number
- 26287
- Firm
- GE Medical Systems Information Technologies
- FEI Number
- 1030184
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 7, 2001
- Posted
- October 15, 2003
- Terminated
- April 15, 2008
- Address
- 4502 Woodland Corporate Blvd., Tampa, FL, 33614
Description
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***.'
Reason
Wrong connector attached to blood pressure cuff.
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.
Distribution
Product was distributed to one distributor in Oregon.
Quantity
100 cuffs