Device 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.
Z-0844-2020
Product summary
- Event
- Event 84635
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80 eaches
- Official record key
device-enforcement:Z-0844-2020
Official wording
Reason: 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
Code information: Lot/Batch Number: PMC 23F19H0224
Distribution pattern: US distribution to SC
Derived failure modes
-
Unknown
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