Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R)… recallZ-0784-2010 · Arrow International Inc · initiated Nov 24, 2009
Terminated All recalls posted in March 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
Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.
Recall details
- Recall number
- Z-0784-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 24, 2009
- Posted by the FDA
- Mar 5, 2010
- Recalling firm
- Arrow International Inc
- Quantity
- 65 kits
- Product code
- DYB
- FDA submissions
- K940079
- Distribution
- The products were shipped to distributors in GA, MD, and VA.
Product description
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
Code information (models, lots, serial numbers)
Product number ASK-29803-SJH. Lot numbers RF9044900 and RF9068155
Other devices under the same FDA submission
15 devices cleared under K940079 — 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 IPN036336Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
- ARROW IPN055903Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
- ARROW IPN928747Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN929679Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN929716Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN929720Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN929737Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN930086Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN930576Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPNB00183Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPNB00179Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN918404Teleflex Incorporated · INTRODUCER, CATHETER2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 53954).
- Z-0783-2010 · TerminatedMAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with …
- Z-0785-2010 · TerminatedMulti-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is ship…
- Z-0786-2010 · TerminatedTwo-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shippe…
- Z-0787-2010 · TerminatedMulti-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)
- Z-0788-2010 · TerminatedMulti-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)
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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