Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue catheter has not been studied
FDA Recall Z-1915-2026 · Posted 2026-04-22
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Recalling FirmARROW INTERNATIONAL, LLC
Recall StatusOpen, Classified
Product CodeLRS
Date Initiated2026-03-11
Product Quantity5
Reason for Recall
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Firm 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
Root Cause
Process control
Distribution Pattern
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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