FDA Recall
Terminated
Radial Artery Catheterization Kit; Model: AK-04220
Recall: Z-1286-2018
·
Initiated October 26, 2017
Recall
- Recall Number
- Z-1286-2018
- Event Number
- 79314
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- DQX
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 26, 2017
- Terminated
- December 10, 2019
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
Description
Radial Artery Catheterization Kit; Model: AK-04220
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.
Action
Teleflex/Arrow sent a letter dated October 26th, 2017. Customers are instructed to discontinue use and quarantine any products with the affected product codes and lot numbers. There is a Recall Acknowledgment Form that is requested to be completed that will allow the return and replacement of the affected product. Consignees without affected product on hand are also asked to return the form.
Distribution
US nationwide distribution, including Puerto Rico.
Quantity
6358