MAC Two-Lumen Central Venous Access kit with Integral… recallZ-2488-2010 · 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-2488-2010
- 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
- 16
- Product code
- DYB
- FDA submissions
- K002507
- Distribution
- The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
Product description
MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
Code information (models, lots, serial numbers)
Product # AK-11142-B, Lot # RF0033311
Other devices under the same FDA submission
16 devices cleared under K002507 — 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 IPN036448Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
- ARROW IPN056804Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls0 reports
- ARROW IPN036456Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls0 reports
- ARROW IPN036827Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall3 reports
- ARROW IPN037139Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN055805Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN919671Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN923736Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN930717Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN036449Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN030354Teleflex Incorporated · INTRODUCER, CATHETER16 reports
- ARROW IPN923911Teleflex Incorporated · Introducer, catheter6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 56363).
- 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-2495-2010 · TerminatedFemoral Artery 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.
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