Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1237-03

Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch...

GE Medical Systems Information Technologies, Inc. / initiated 2001-03-07 / Terminated

GE Medical Systems Information Technologies began a recall of Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part... on . The reason FDA records is "Wrong connector attached to blood pressure cuff". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1237-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Medical Systems Information Technologies, Inc.
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***.'
Reason for recall
Wrong connector attached to blood pressure cuff.
FDA 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 in commerce
100 cuffs
Distribution
Product was distributed to one distributor in Oregon.
Product codes and lots
Lot 0601