Z-2699-2017Class II

Arrow Glide Thru Peel-Away Sheath/Dilator Introducer

Name: Z-2699-2017 Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Creator: Arrow International Inc
Published: 2017-06-12
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-06-12 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Arrow Glide Thru Peel-Away Sheath/Dilator Introducer on 2017-06-12. FDA classified it as Class II and gives the reason as "Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2699-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Posted: 2017-06-27
Terminated: 2018-09-06
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Product code: DYB Introducer, Catheter
Reason for recall: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
Root cause tag: design
FDA root cause: Device Design
Action: Teleflex/Arrow International mailed an Urgent Medical Device Recall Notification Letter to affected customers on 06/12/2017 to inform them of the issue. Arrow requested that customers examine their inventory immediately for the affected lots and discontinue use and quarantine any products with the associated product codes identified in the notice and complete the Recall Acknowledgement Form and fax back to the number included in the notice.
Quantity in commerce: 9,037 units in the U.S. and 4,505 Internationally
Distribution: Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Product codes and lots: Device Listing # D184260 Material # PL-01055

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2699-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2698-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07
Z-2699-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07

Product code DYB

K122854Class IIArrow Glidethru Peel-Away Sheath/dilator IntroducerArrow International (Subsidiary of Teleflex Inc.) / cleared 2013-01-04

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)