ClearanceBrief
Recall Z-0581-04 ยท CBP Valve, Non-Rebreathing

Rusch Inc

One Way Valve/Female to Male Flow, 22 mm I.D./22 mm O.D., Ref 396798, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each Manufactured for and Distributed by RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098, Made in Taiwan.

DateJul 20, 2004 (initiated Feb 3, 2004)
StatusTerminated
ReasonValve cap may become loose and enter the air circuitry.
Root causeOther
ActionConsignees were notified on 2/3/2004 via certified mail and telephone.
Quantity13300 pieces
DistributionNationwide and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.