Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0020-04

Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe...

Vital Concepts, Inc. / initiated 2003-07-11 / Terminated

Vital Concepts, Inc. began a recall of Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog... on . The reason FDA records is "The suction valve may become stuck in the 'suction on' position under vacuum". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0020-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Vital Concepts, Inc.
Product
Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Product code
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall
The suction valve may become stuck in the 'suction on' position under vacuum.
FDA root cause
Other
Action
A request for product return was sent to each customer beginning on July 11, 2003.
Quantity in commerce
252
Distribution
Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan
Product codes and lots
lots 50905127 and 50905036.