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
FDA Recall Z-0011-2011 · Posted 2010-10-06
Recalling FirmMaquet Inc.
Recall StatusTerminated
Product CodeDWE
Date Initiated2010-09-07
Date Terminated2012-09-25
Product Quantity22 items
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: USA State of IL and country of the Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.