Recall Z-1769-2017 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Datascope Corporation
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung
| Date | Mar 23, 2017 (initiated Feb 16, 2017) |
| Status | Terminated |
| Reason | A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port. |
| Root cause | Device Design |
| Action | Maquet Inc. was notified by their customer on January 1, 2017. This was a reverse notification. The one impacted customer said they will not return the product since they can easily correct the pigtail connection before use. For further questions regarding this recall, please call (973) 709-7442. |
| Quantity | 21 kits |
| Distribution | US Distribution to the 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 |