Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.
Recall
- Recall Number
- Z-0844-2020
- Event Number
- 84635
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- DQX
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- December 12, 2019
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
Description
Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.
The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
Arrow International issued an " Urgent Medical Device Recall Notice" to its US consignee on 12th Dec 2019 via FedEx 2-day mail. The letter states reason for recall, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Questions contact your local sales representative or Customer Service at 1-866-396-2111.
US distribution to SC
80 eaches