MAC (TM) Two Lumen Central Venous Access Kit with… recallZ-0783-2010 · 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-0783-2010
- 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
- 117 kits
- Product code
- DYB
- FDA submissions
- K011761
- Distribution
- The products were shipped to distributors in GA, MD, and VA.
Product description
MAC (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 7 - 7.5 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
Code information (models, lots, serial numbers)
Product number ASK-21242-UVA2. Lot numbers RF9068459 and RF9060775
Other devices under the same FDA submission
57 devices cleared under K011761 — 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 IPN036821Teleflex Incorporated · INTRODUCER, CATHETER2 recalls8 reports
- ARROW IPN036830Teleflex Incorporated · INTRODUCER, CATHETER2 recalls3 reports
- ARROW IPN036452Teleflex Incorporated · INTRODUCER, CATHETER2 recalls3 reports
- ARROW IPN037022Teleflex Incorporated · INTRODUCER, CATHETER2 recalls1 report
- ARROW IPN036838Teleflex Incorporated · INTRODUCER, CATHETER2 recalls1 report
- ARROW IPN036446Teleflex Incorporated · INTRODUCER, CATHETER2 recalls1 report
- ARROW IPN037258Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN037610Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN927550Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls0 reports
- ARROW IPN929229Teleflex Incorporated · Introducer, catheter2 recalls0 reports
- ARROW IPN036826Teleflex Incorporated · INTRODUCER, CATHETER1 recall6 reports
- ARROW IPN036444Teleflex Incorporated · INTRODUCER, CATHETER1 recall5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 53954).
- Z-0784-2010 · TerminatedPercutaneous 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…
- 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.
How recalls are matched to devices · Editorial policy · Report an error on this page