Recall Z-1666-2011 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Maquet Cardiovascular, LLC
Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation duri
| Date | Mar 16, 2011 (initiated Feb 23, 2011) |
| Status | Terminated |
| Reason | Tubing connectors incorrectly packaged and labeled. |
| Root cause | Other |
| Action | The firm, Maquet, sent a "PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION" letter dated February 22, 2011 via Federal Express to its customer. The letter described the product, problem and the action to be taken. The customer was instructed to examine their inventory immediately to identify and remove the affected connectors and complete and return the attached RECALL- Device Corrective Action Response Form via fax to Director of Regulatory Affairs at (973) 709-7016 or email: whitney.torning@maquet.com. If you have any additional questions, please contact your local MAQUET Cardiova |
| Quantity | 40 BEQ-HG 0284 3/8" x 3/8" Lot 70041098 Connectors |
| Distribution | Nationwide distribution: USA state of CA. |
| 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 |