Z-1912-2026Class II

PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code...

Name: Z-1912-2026 PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code...
Creator: Arrow International, Llc
Published: 2026-03-11
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2026-03-11 / Open, Classified / root cause: manufacturing process

FDA source

ARROW INTERNATIONAL, LLC began a recall of PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow... on 2026-03-11. FDA classified it as Class II and gives the reason as "Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1912-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-11
Posted: 2026-04-22
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Product code: OFL Percutaneous Sheath Introducer Kit
Reason for recall: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 03/18/2026, the firm sent via FedEx-2-day an "URGENT MEDICAL DEVICE RECALL" Letter informing customers that Ferndale Laboratories issued a Field Safety Notice (FSN) to inform users of multiple complaints reporting the butyrate tubing of the Mastisol Liquid Adhesive vial cracked during actuation. According to the Ferndale Laboratories FSN, one lot of MASTISOL Liquid Adhesive was exposed to a double sterilization cycle which may have contributed to the butyrate tubing becoming brittle and susceptible to cracking during actuation. Medical Facilities should: 1. Immediately check inventory for product within the scope of this recall and cease use and distribution of affected product and immediately quarantine the affected product. 2. For impacted product, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and contact Teleflex Customer Service utilizing one of the following methods: a. Fax, including Attn: Customer Service , or email customer service using the point of contact details outlined on Page 3 with a copy of Appendix 1 OR b. Using the online FSN Portal, complete the acknowledgement form virtually using the following link: https://fca.myteleflex.com/en/recall/000606 Note: Option B is solely applicable to customers who received product direct from Teleflex. 3. For impacted product, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and return the form to Teleflex at the contact details provided. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Distributor should: 1. Provide a copy of this recall notice to all customers who have received impacted product. Each customers is then required to complete the Acknowledgement Form and return it to Distributor. 2. Request immediate check of inventory, cease use and distribution of, and quarantine, affected products and returned to Teleflex. For questions-contact customer service at 1-866-396-2111 or email Recalls@telefle
Quantity in commerce: 115
Distribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Product codes and lots: Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1912-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1910-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1911-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1912-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1913-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1914-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1915-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1916-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1917-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

Product code OFL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)