Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sh
FDA device recall Z-1163-2018 · posted 2018-03-05 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
- Action taken
- On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions: 1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory. 2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 18,124 total
- Distribution
- Nationwide Distribution
- Date initiated
- 2017-11-14
- Date posted
- 2018-03-05
- Date terminated
- 2019-07-15
- 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 |