Vital Concepts, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 6

Known Identifiers & Locations

FEI Numbers 1000115375
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (6)

Recall # Product Description Initiation Date Status Action
Z-0020-04 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. Reason: The suction valve may become stuck in the 'suction on' position under vacuum. 2003-07-11 Terminated View Details
Z-0021-04 Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec. Reason: The suction valve may become stuck in the 'suction on' position under vacuum. 2003-07-11 Terminated View Details
Z-0022-04 HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan. Reason: The suction valve may become stuck in the 'suction on' position under vacuum. 2003-07-11 Terminated View Details
Z-0023-04 HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH Reason: The suction valve may become stuck in the 'suction on' position under vacuum. 2003-07-11 Terminated View Details
Z-0024-04 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. Reason: The suction valve may become stuck in the 'suction on' position under vacuum. 2003-07-11 Terminated View Details
Z-0025-04 Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing, Disposable (single use only), sterile, latex free. Catalog # 55050. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Reason: The suction valve may become stuck in the 'suction on' position under vacuum. 2003-07-11 Terminated View Details

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