Femoral Arterial Line recallZ-2201-2016 · Arrow International Inc · initiated Jun 2, 2016
Class II Terminated All recalls posted in July 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
Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
FDA root cause category: Labeling mix-ups
What the company is doing
Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to [email protected]. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Recall details
- Recall number
- Z-2201-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 2, 2016
- Posted by the FDA
- Jul 12, 2016
- Recalling firm
- Arrow International Inc
- Quantity
- 50 units in total
- Product code
- DQX
- FDA submissions
- K810675
- Distribution
- US distribution in the states of TN and KY.
Product description
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
Code information (models, lots, serial numbers)
Lot/Batch Numbers: 23F14M0829, 23F14M0986
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 74489).
- Z-2202-2016 · TerminatedFemoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arteria…
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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