LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
FDA device recall Z-2568-2014 · posted 2014-09-03 · Terminated
Recall details
- Recalling firm
- Datascope Corporation
- Reason for recall
- During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
- Action taken
- Maquet Inc.is sued an Urgent Medical Device Recall Letter/ Fax Back Form dated August 11, 2014. Customers are asked to quarantine the affected product and upon return they will be provided with an exchanged unaffected product. The attached form should be completed an returned to Maquet Inc. Questions can be directed to Maquet Technical Support at (888) 627-8383 - Press option "3" followed by option "1" Monday through Friday between the hours of 8 am and 5 pm (EST).
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- one unit
- Distribution
- US Distribution to TX.
- Date initiated
- 2014-08-11
- Date posted
- 2014-09-03
- Date terminated
- 2015-02-05
- Location
- Fairfield, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES (K041281) | Datascope Corp. | 2004-06-07 |