Arrow Pediatric Two-Lumen Central Venous Catheterization… recallZ-1653-2009 · Arrow International Inc · initiated Jun 17, 2009
Terminated All recalls posted in July 2009
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
The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.
FDA root cause category: Process design
What the company is doing
Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.
Recall details
- Recall number
- Z-1653-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 17, 2009
- Posted by the FDA
- Jul 7, 2009
- Recalling firm
- Arrow International Inc
- Quantity
- 3019 units
- Product code
- DQY
- FDA submissions
- K862056
- Distribution
- Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.
Product description
Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
Code information (models, lots, serial numbers)
Catalog number: CS-14502, Lot numbers: RF7019488 and RF7029944.
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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