Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, a
FDA device recall Z-2493-2010 · posted 2010-09-25 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
- Action taken
- The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 15
- Distribution
- The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
- Date initiated
- 2010-07-29
- Date posted
- 2010-09-25
- Date terminated
- 2012-07-05
- 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 |
|---|---|---|
| ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER (K993691) | Arrow Intl., Inc. | 2000-03-08 |