Multi-Lumen Central Venous Catheterization recallZ-0076-2015 · Arrow International Inc · initiated Sep 18, 2014
Class II Terminated All recalls posted in October 2014
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 International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.
FDA root cause category: Labeling False and Misleading
What the company is doing
Arrow International sent an Medical Device Advisory Notifications letter dated September 18, 2014, sent to direct accounts to notify them about the product, problem, and actions to be taken. Arrow International, Inc. (Arrow) is notifying customers that the label on the outer corrugate for the above mentioned product code and lot number is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date. Arrow International, Inc. is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Recall details
- Recall number
- Z-0076-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 18, 2014
- Posted by the FDA
- Oct 16, 2014
- Recalling firm
- Arrow International Inc
- Quantity
- 65
- Product code
- DQY
- FDA submissions
- K862056
- Distribution
- US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.
Product description
Multi-Lumen Central Venous Catheterization Kit
Code information (models, lots, serial numbers)
Catolog No - AK-12703 lot number RF3039028
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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