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
This recall has been terminated (originally issued October 6, 2010).
- Company
- Maquet Inc.
- Recall Initiated
- September 7, 2010
- Posted
- October 6, 2010
- Terminated
- September 25, 2012
- Recall Number
- Z-0011-2011
- Quantity
- 22 items
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: USA State of IL and country of the Netherlands.
Lot / Code Info
Lot number 70052718 and 70048867
Root Cause
Device Design
Action Taken
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.