ClearanceBrief
Recall Z-0259-04 ยท BYY Tube, Aspirating, Flexible, Connecting

Vital Concepts, Inc.

Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan.

DateJul 20, 2004 (initiated Nov 7, 2003)
StatusTerminated
ReasonThe probe may separate from the cannula.
Root causeOther
ActionRecall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.
Quantity70
DistributionArizona, Illinois, Indiana, Michigan and Pennsylvania.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K934382VCI SUCTION/IRRIGATION TUBING SET
Vital Concepts, Inc., Feb 1, 1994