Arrow Percutaneous Sheath Introducer Kits recallZ-1713-2014 · Arrow International Inc · initiated Apr 14, 2014
Class II Terminated All recalls posted in June 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 is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.
FDA root cause category: Process control
What the company is doing
Teleflex/Arrow International sent an Urgent Medical Device Recall Notification letter dated April 17, 2014, to distributors and end users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product and to complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935 to return product. Customers would be contacted by a customer service representative for a Return Goods Authorization (RGA) Numbers and would be provided instructions for the return of the product. Customers should complete the form whether they have affected product or not. Customers with questions were instructed to call 1-800-343-2935. For questions regarding this recall call 610-378-0131.
Recall details
- Recall number
- Z-1713-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 14, 2014
- Posted by the FDA
- Jun 4, 2014
- Recalling firm
- Arrow International Inc
- Quantity
- 15424
- Product code
- DYB
- FDA submissions
- K780532
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
Product description
Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Code information (models, lots, serial numbers)
Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G0400 ASK-09903-CMC RF3064673 NL-09903-S 23F13G0630 AK-09903-LFSP RF3065449 ASK-09903-CMC 23F13G0343 NR-09903-S 23F13G0180 AK-09903-S 23F13G0204 ASK-09903-NKC 23F13G0336 SI-09903-E RF3064710 AK-09903-S RF3064956 ASK-09903-TJ 23F13G0567 SI-09903-E RF3064915 AK-09903-S 23F13H0195 CDC-09903-1A RF3065316
Other devices under the same FDA submission
46 devices cleared under K780532 — 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 IPN036824Teleflex Incorporated · INTRODUCER, CATHETER2 recalls2 reports
- ARROW IPN037025Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN029661Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN039798Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN921749Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN926611Teleflex Incorporated · Introducer, catheter2 recalls0 reports
- ARROW IPN036351Teleflex Incorporated · INTRODUCER, CATHETER1 recall2 reports
- ARROW IPN037011Teleflex Incorporated · INTRODUCER, CATHETER1 recall1 report
- ARROW IPN038521Teleflex Incorporated · INTRODUCER, CATHETER1 recall1 report
- ARROW IPN036682Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
- ARROW IPN036858Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
- ARROW IPN036931Teleflex Incorporated · INTRODUCER, CATHETER1 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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