Z-1713-2014Class II

Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or...

Name: Z-1713-2014 Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or...
Creator: Arrow International Inc
Published: 2014-04-14
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2014-04-14 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central... on 2014-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1713-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Posted: 2014-06-04
Terminated: 2016-10-14
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Product code: DYB Introducer, Catheter
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 15424
Distribution: Worldwide Distribution - USA (nationwide) and Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1713-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1713-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04

Product code DYB

K780532Class IIPercutaneous Sheath Introducer KitArrow Intl., Inc. / cleared 1978-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)