FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (

FDA device recall Z-1913-2026 · posted 2026-04-22 · Open, Classified

Recall details

Recalling firm

ARROW INTERNATIONAL, LLC

Reason for recall

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

BSO

Quantity affected

190

Distribution

U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Date initiated

2026-03-11

Date posted

2026-04-22

Location

Morrisville, NC

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