ClearanceBrief
Recall Z-0024-04 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Vital Concepts, Inc.

Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

DateOct 15, 2003 (initiated Jul 11, 2003)
StatusTerminated
ReasonThe suction valve may become stuck in the 'suction on' position under vacuum.
Root causeOther
ActionA request for product return was sent to each customer beginning on July 11, 2003.
Quantity160
DistributionArizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K934382VCI SUCTION/IRRIGATION TUBING SET
Vital Concepts, Inc., Feb 1, 1994
K960616VITAFLOW SUCTION/ASPIRATION TUBING SET
Vital Concepts, Inc., May 6, 1996