Z-0844-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- December 12, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 eaches
Product 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.
Reason for Recall
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
Distribution Pattern
US distribution to SC
Code Information
Lot/Batch Number: PMC 23F19H0224