Arterial Access Tray, introducer catheter; Model: GU-04020
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Recall
- Recall Number
- Z-1287-2018
- Event Number
- 79314
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- DYB
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 26, 2017
- Terminated
- December 10, 2019
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
Description
Arterial Access Tray, introducer catheter; Model: GU-04020
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.
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.
US nationwide distribution, including Puerto Rico.
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