Arrow-Howes (TM) Multi Lumen Central Venous Catheterization… recallZ-0898-2011 · Arrow International Inc · initiated Nov 9, 2010
Terminated All recalls posted in January 2011
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
One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit.
FDA root cause category: Process control
What the company is doing
The recalling firm issued Urgent Medical Recall letters dated 11/9/10 to inform their customers of the problem and the need to return any unused product. Customers are to check their stock for the affected product, contact Arrow Customer Service for a Return Authorization Number, and complete the enclosed Recall Acknowledgement & Stock Status Form. For customers with no affected product in stock, the form should still be completed and also faxed to Arrow Customer Service. Affected product should be returned along with the original completed form to Arrow International, Inc. Arrow will replace the affected product once it has been returned. Additional information or clarification can be obtained from Arrow Customer Service at 1-919-361-3964.
Recall details
- Recall number
- Z-0898-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 9, 2010
- Posted by the FDA
- Jan 12, 2011
- Recalling firm
- Arrow International Inc
- Quantity
- 1150 units
- Product code
- DQY
- FDA submissions
- K862056
- Distribution
- International Distribution Only -- Argentina and Columbia.
Product description
Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. Permits venous access to the central circulation.
Code information (models, lots, serial numbers)
Lot/Serial Number: CF9065974.
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.
How recalls are matched to devices · Editorial policy · Report an error on this page