Radial Artery Catheterization Kit with Sharps Safety… recallZ-2741-2016 · Arrow International Inc · initiated Aug 8, 2016
Class II Terminated All recalls posted in September 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Shipping carton labeling error.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2741-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 8, 2016
- Posted by the FDA
- Sep 7, 2016
- Recalling firm
- Arrow International Inc
- Quantity
- 690 kits
- Product code
- DQX
- FDA submissions
- K810675
- Distribution
- Nationwide Distribution to OH, IN, TN, NC, and KY.
Product description
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.
Code information (models, lots, serial numbers)
Device Listing # D025180
Other devices under the same FDA submission
117 devices cleared under K810675 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
- ARROW IPN037007Teleflex Incorporated · WIRE, GUIDE, CATHETER3 recalls2 reports
- ARROW IPN036829Teleflex Incorporated · Wire, guide, catheter3 recalls1 report
- ARROW IPN036983Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls6 reports
- ARROW IPN037256Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls2 reports
- ARROW IPN036999Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls1 report
- ARROW IPN037023Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037000Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN036992Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN036853Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037005Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 74986).
- Z-2740-2016 · TerminatedArterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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