Recalls / —
—#149019
Product
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
- FDA product code
- DQX — Wire, Guide, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K810675
- Affected lot / code info
- Device Listing # D025180
Why it was recalled
Shipping carton labeling error.
Root cause (FDA determination)
Process control
Action the firm took
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 recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- Nationwide Distribution to OH, IN, TN, NC, and KY.
Timeline
- Recall initiated
- 2016-08-08
- Posted by FDA
- 2016-09-07
- Terminated
- 2017-08-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.