VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San

FDA device recall Z-3272-2011 · posted 2011-09-20 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular, LLC

Reason for recall

During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.

Action taken

MAQUET Cardiovascular, LLC, sent an "Urgent Device Removal/Immediate Action Required" letter dated December 17, 2009, to all affected customers. The letter identified the recalled products, the problem, and the actions needed to be taken. The letters asked customers to examine their stocks (inventory) immediately to determine if they had any affected lot numbers and to discontinue dispensing (distributing) the lot. The letter states that customers are to complete the attached Field Action Response form regardless of whether or not the affected products are located in their inventory. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. The letter instructed all users to return all unused affected products to MAQUET. For customer's convenience, all affected products that are returned may be exchanged with other unaffected VASOVIEW Endoscopic Vessel Harvesting System by overnight delivery. Questions should be directed to MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GEI

Quantity affected

72 units

Distribution

Nationwide Distribution (USA) including the states of: AL, AZ, CA, CT, FL, KS, KY, IL, IN, MI, MO, ND, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, WA, and WI.

Date initiated

2009-12-17

Date posted

2011-09-20

Date terminated

2011-09-21

Location

Wayne, NJ

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