FDA Device Recall Z-0011-2011: Maquet Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0011-2011.

Recall Res Number

Z-0011-2011

Recalling Firm / Manufacturer

Maquet Inc.

FEI Number

3008355164

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-09-07

Date Posted

2010-10-06

Date Terminated

2012-09-25

Product Code

DWE

Event Number

56728

Product Quantity

22 items

Product Description MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400

Reason for Recall Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line.

Action Details Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions. All firms are to coomplete and return the Corrective Action Response Form. Maquet Customer Service can bre contacted at 800-777-4222.

Distribution Pattern Worldwide Distribution: USA State of IL and country of the Netherlands.

Code Information / Serial Numbers Lot number 70052718 and 70048867

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Medical Device Recall: Z-0011-2011

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer