Z-2576-2018Class II

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch...

Name: Z-2576-2018 Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch...
Creator: Arrow International Inc
Published: 2018-05-23
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-05-23 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The... on 2018-05-23. FDA classified it as Class II and gives the reason as "Product contains dry natural rubber latex. Label states Latex Free". 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-2576-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-23
Posted: 2018-07-30
Terminated: 2020-05-20
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Product code: DYB Introducer, Catheter
Reason for recall: Product contains dry natural rubber latex. Label states Latex Free.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 23, 2018, Arrow International issued Urgent Medical Device Recall notices and response forms to their customer. Customers are advised to take the following actions: 1. Immediately discontinue distribution and quarantine affected product. 2. Using the provided customer letter and Recall Acknowledgement Form templates, customers who have further distributed product should contact those individuals. 3. To return affected products from your inventory, complete and return the Recall Acknowledgement Form via to 1-855-419-8507, Attn: Customer Service or email to [email protected]. 4. If you and your customers have no affected stock, please complete and return the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. 5. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 60 units
Distribution: Puerto Rico
Product codes and lots: Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2576-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2576-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-30

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)