Device product

Radial Artery Catheterization Kit; Model: AK-04018

Z-1281-2018

October 26, 2017

Class II

Product summary

Firm: Arrow International Inc
Event: Event 79314
Status: Terminated
Classification: Class II
Quantity: 930
Official record key: device-enforcement:Z-1281-2018

Official wording

Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Code information: Lots: 13F16H0183, 13F17E0728, 13F17F0525, 23F16E1188, 23F16H0911; Expiration dates: October 2018 through March 2020

Distribution pattern: US nationwide distribution, including Puerto Rico.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.