ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to prov
FDA device recall Z-2136-2016 · posted 2016-07-06 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
- Action taken
- Arrow mailed an Urgent Medical Device Recall Notification letter to customers requesting they immediately discontinue distribution and quarantine any products with the affected lot numbers. A Recall Acknowledgement Form was included with the notification letter for customers to complete and email to recalls @teleflex.com indicating the amount of product on hand.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 1, 170 units
- Distribution
- US Nationwide Distribution: in the states of MA, CA, IL, TN, IL
- Date initiated
- 2016-06-02
- Date posted
- 2016-07-06
- Date terminated
- 2017-08-25
- 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 |