Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 91
FDA device recall Z-3057-2011 · posted 2011-08-22 · Terminated
Recall details
- Recalling firm
- Maquet Inc.
- Reason for recall
- HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction.
- Action taken
- Maquet sent an URGENT PRODUCT RECALL NOTIFICATION letter dated June 17, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to acknowledge receipt of the notification by completing and sending back the attached response form whether or not they have any affected product, fax to 973-807-9210 no later than June 30, 2011. For any questions customers were instructed to contact thier local MAQUET representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 229 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-06-20
- Date posted
- 2011-08-22
- Date terminated
- 2012-10-16
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM (K943803) | Janus Biomedical, Inc. | 1996-01-30 |