ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the cen
FDA device recall Z-1082-2015 · posted 2015-02-10 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
- Action taken
- An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 1195
- Distribution
- Nationwide
- Date initiated
- 2015-01-02
- Date posted
- 2015-02-10
- Date terminated
- 2016-10-25
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |