ClearanceBrief
Recall Z-1237-03 ยท

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***.'

DateOct 15, 2003 (initiated Mar 7, 2001)
StatusTerminated
ReasonWrong connector attached to blood pressure cuff.
Root causeOther
ActionThe 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.
Quantity100 cuffs
DistributionProduct was distributed to one distributor in Oregon.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.