FDA Device Recall Z-0024-04: Vital Concepts, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0024-04.

Recall Res Number

Z-0024-04

Recalling Firm / Manufacturer

Vital Concepts, Inc.

FEI Number

1000115375

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2003-07-11

Date Posted

2003-10-15

Date Terminated

2004-04-12

Product Code

GCY

Event Number

27131

Product Quantity

160

Product Description 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 for Recall The suction valve may become stuck in the 'suction on' position under vacuum.

Action Details A request for product return was sent to each customer beginning on July 11, 2003.

Distribution Pattern Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan

Code Information / Serial Numbers los 994985, 994986 and 995044.

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Medical Device Recall: Z-0024-04

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer