Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline
FDA device recall Z-1769-2017 · posted 2017-03-23 · Terminated
Recall details
- Recalling firm
- Datascope Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- 21 kits
- Distribution
- US Distribution to the state of : CA.
- Date initiated
- 2017-02-16
- Date posted
- 2017-03-23
- Date terminated
- 2019-03-21
- Location
- Fairfield, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HLM TUBING SET WITH BIOLINE COATING (K080592) | Maquet Cardiopulmonary, AG | 2008-09-11 |