Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to centra
FDA device recall Z-1879-2017 · posted 2017-04-10 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
- Action taken
- Arrow International mailed an Urgent Medical Device Notification Letter dated April 4, 2017, to affected customers to inform them of the issue. Customers were asked to discontinue use immediately and return product by completing the enclosed Recall Acknowledgement Form then emailing it to recalls@teleflex.com or faxing it to 1-855-419-8507. A Customer Service Representative will provide a Return Goods Authorization Number for the products' return. For questions regarding this recall call 866-246-6990.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 310 units
- Distribution
- US Distribution to NJ, IL, and PA
- Date initiated
- 2017-03-17
- Date posted
- 2017-04-10
- Date terminated
- 2020-03-24
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER (K071538) | Arrow International, Inc. | 2007-08-30 |