Arrow Arterial Catheterization Kit (Arrow) – MR symbol error (2019)
An incorrect medical device label symbol can cause potential usage misunderstanding.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Arrow International Inc
Lot Codes / Batch Numbers
Lot/Batch Number: PMC 23F19H0224
Products Sold
Lot/Batch Number: PMC 23F19H0224
Arrow International Inc is recalling Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer due to The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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 recalls@teleflex.com. 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 recalls@teleflex.com. Questions contact your local sales representative or Customer Service at 1-866-396-2111.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
SC
Update History
Changes reported by FDA
Update – March 8, 2026
The FDA updated the recommended consumer action
Page updated: Mar 8, 2026