Z-2329-2017Class II

1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier...

Name: Z-2329-2017 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier...
Creator: Arrow International Inc
Published: 2017-05-09
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-05-09 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer... on 2017-05-09. FDA classified it as Class II and gives the reason as "Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2329-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Posted: 2017-06-12
Terminated: 2018-09-17
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Product code: DYB Introducer, Catheter
Reason for recall: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 27,485 units distributed in U.S, 4,371 units distributed internationally
Distribution: Worldwide Distribution - US (nationwide) and Canada
Product codes and lots: Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2329-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2327-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2328-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2329-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2330-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2331-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2332-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2333-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2334-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2335-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2336-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2337-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2338-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12

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)