RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar to individual unit labeling, except for, ***Qty 50 ea.
FDA Recall Z-0579-04 · Posted 2004-07-20
Recalling FirmRusch Inc
Recall StatusTerminated
Product CodeCBP
Date Initiated2004-02-03
Date Terminated2006-03-21
Product Quantity13560 pieces
Reason for Recall
Valve cap may become loose and enter the air circuitry.
Firm Action
Consignees were notified on 2/3/2004 via certified mail and telephone.
Root Cause
Other
Distribution Pattern
Nationwide and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.