Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Recall
- Recall Number
- Z-2740-2016
- Event Number
- 74986
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- DQX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 8, 2016
- Posted
- September 7, 2016
- Terminated
- August 22, 2017
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
Description
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Shipping carton labeling error.
Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. Customers with questions were instructed to call 1-866-246-6990.
Nationwide Distribution to OH, IN, TN, NC, and KY.
690 kits