ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized f
FDA device recall Z-1233-2015 · posted 2015-03-02 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
- Action taken
- Arrow International notified Users, Distributors, Risk Managers by letter dated February 5, 2015. The letter explains the labeling error and requests immediately discontinue use and quarantine product. Customers were instructed to complete the Recall Acknowledgement Form and return by fax to 1-855-419-8507 whether they have or do not have the affected product. Customers with questions were instructed to contact their local sales representataive or Customers Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 165 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Belgium
- Date initiated
- 2015-02-05
- Date posted
- 2015-03-02
- Date terminated
- 2016-10-26
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 (K021462) | Arrow Intl., Inc. | 2002-06-06 |