Femoral Artery Catheterization Set recallZ-2495-2010 · Arrow International Inc · initiated Jul 29, 2010
Terminated All recalls posted in September 2010
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
Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
FDA root cause category: Mixed-up of materials/components
What the company is doing
The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
Recall details
- Recall number
- Z-2495-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 29, 2010
- Posted by the FDA
- Sep 25, 2010
- Recalling firm
- Arrow International Inc
- Quantity
- 19
- Product code
- DQX
- FDA submissions
- K810675
- Distribution
- The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
Product description
Femoral Artery Catheterization Set
Code information (models, lots, serial numbers)
Product # GH-04150, Lot # RF0019161
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 56363).
- Z-2488-2010 · TerminatedMAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
- Z-2491-2010 · TerminatedMulti-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS Catheter and Sharps Safety Features
- Z-2493-2010 · TerminatedTwo-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions
- Z-2494-2010 · TerminatedArterial Catheterization Set
- Z-2496-2010 · TerminatedTwo-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
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.
How recalls are matched to devices · Editorial policy · Report an error on this page