Recall Z-0011-2011 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Maquet Inc.
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
| Date | Oct 6, 2010 (initiated Sep 7, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 22 items |
| Distribution | Worldwide Distribution: USA State of IL and country of the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080592 | HLM TUBING SET WITH BIOLINE COATING Maquet Cardiopulmonary, AG, Sep 11, 2008 |