Maquet HLM Tubing Pack; Bioline Coating
FDA device recall Z-2401-2010 · posted 2010-09-12 · Terminated
Recall details
- Recalling firm
- Maquet Inc.
- Reason for recall
- The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.
- Action taken
- Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- 5 units
- Distribution
- Distribution: Pennsylvania
- Date initiated
- 2010-07-13
- Date posted
- 2010-09-12
- Date terminated
- 2011-08-10
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JOSTRA HLM TUBING SET (K053025) | Maquet Cardiopulmonary, AG | 2005-11-10 |