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ARROW recallZ-1917-2026 · Arrow International, LLC · initiated Mar 11, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Arrow International, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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

Recall details

Recall number
Z-1917-2026
Status
Open, Classified
Initiated by the company
Mar 11, 2026
Posted by the FDA
Apr 22, 2026
Recalling firm
Arrow International, LLC
Quantity
95
Product code
OFC
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98618).

Sources and updates

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