Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex… recallZ-1965-2013 · Arrow International Inc · initiated Jul 31, 2013
Class II Terminated All recalls posted in August 2013
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
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
FDA root cause category: Labeling Change Control
What the company is doing
An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.
Recall details
- Recall number
- Z-1965-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 31, 2013
- Posted by the FDA
- Aug 14, 2013
- Recalling firm
- Arrow International Inc
- Quantity
- 156
- Product code
- DQY
- FDA submissions
- K862056
- Distribution
- AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
Product description
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Code information (models, lots, serial numbers)
Catalog # AK-17702-CDC, lot # RF2083258
Other devices under the same FDA submission
132 devices cleared under K862056 — 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 IPN030909Teleflex Incorporated · CATHETER, PERCUTANEOUS154 reports
- ARROW IPN917021Teleflex Incorporated · Catheter, percutaneous2 recalls0 reports
- ARROW IPN917027Teleflex Incorporated · Catheter, percutaneous2 recalls0 reports
- ARROW IPN036043Teleflex Incorporated · CATHETER, PERCUTANEOUS88 reports
- ARROW IPN037105Teleflex Incorporated · CATHETER, PERCUTANEOUS1 recall3 reports
- ARROW IPN030885Teleflex Incorporated · Catheter, percutaneous52 reports
- ARROW IPN036710Teleflex Incorporated · CATHETER, PERCUTANEOUS1 recall0 reports
- ARROW IPN037179Teleflex Incorporated · CATHETER, PERCUTANEOUS1 recall0 reports
- ARROW IPN037134Teleflex Incorporated · CATHETER, PERCUTANEOUS1 recall0 reports
- ARROW IPN917022Teleflex Incorporated · Catheter, percutaneous1 recall0 reports
- ARROW IPN917023Teleflex Incorporated · Catheter, percutaneous1 recall0 reports
- ARROW IPN917025Teleflex Incorporated · Catheter, percutaneous1 recall0 reports
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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