ARROW INTERNATIONAL, LLC: Arrowg+ard Blue MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

Recall number

Z-1917-2026

Recalling firm

ARROW INTERNATIONAL, LLC

Product

Arrowg+ard Blue MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

Status

Open, Classified

Initiated

2026-03-11

Posted

2026-04-22

Terminated

not on file

Reason

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

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

95

Distribution

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

Lot, serial or model codes

Product Code: ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 Batch Number: 33F25M0671

510(k) numbers

not on file

PMA numbers

not on file

Product code

OFC

Firm FEI

3013162291

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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