Recall Z-0579-04 ยท CBP Valve, Non-Rebreathing
Rusch Inc
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.
| Date | Jul 20, 2004 (initiated Feb 3, 2004) |
| Status | Terminated |
| Reason | Valve cap may become loose and enter the air circuitry. |
| Root cause | Other |
| Action | Consignees were notified on 2/3/2004 via certified mail and telephone. |
| Quantity | 13560 pieces |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.