Arrow International Class II Recall of Radial Artery Catheterization Kit
Summary
Arrow International, LLC initiated a Class II recall for 675 Arrow Radial Artery Catheterization Kits (product codes ASK-04220-UCL1, ASK-04020-EUH2, ASK-04020-FMC, ASK-04020-MMC) after receiving notice from supplier Ferndale Laboratories that liquid adhesive was incorrectly manufactured. The recall stems from a Field Safety Notice reporting cracked butyrate tubing in Mastisol Liquid Adhesive vials, caused by exposure to a double sterilization cycle that made the tubing brittle and susceptible to cracking during actuation. Products were distributed nationwide to medical facilities in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia. The FDA determined the root cause was process control.
“The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.”
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What changed
Arrow International, LLC initiated a Class II medical device recall for its Arrow Radial Artery Catheterization Kit after receiving notification from Ferndale Laboratories that a supplier manufacturing defect in the liquid adhesive resulted in brittle butyrate tubing prone to cracking during use. The FDA determined the root cause was inadequate process controls. Healthcare facilities holding affected products (4 specific product codes across 4 batch/lot numbers) must immediately cease use, quarantine inventory, and contact Teleflex Customer Service to arrange return and credit. Distributors must forward recall notices to affected customers and coordinate returns to Teleflex.
Medical facilities should immediately audit their catheter and vascular access product inventories for the affected product codes and batch numbers. This recall highlights supply chain quality control risks for medical devices that incorporate components from external suppliers—specifically liquid adhesives used in combination products. Facilities relying on Teleflex or Arrow International products should verify their supplier quality notification processes are capturing Field Safety Notices from all component manufacturers.
What to do next
- 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.
- Contact Teleflex Customer Service at 1-866-396-2111 or email Recalls@teleflex.com to initiate return and credit processing.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 2 Device Recall ARROW RADIAL ARTERY CATHETERIZATION KIT
- Databases
| 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards |
| CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | |
| New Search | ) |
| | Class 2 Device Recall ARROW RADIAL ARTERY CATHETERIZATION KIT | |
| Date Initiated by Firm | March 11, 2026 |
|---|---|
| Date Posted | April 22, 2026 |
| Recall Status | Open , Classified |
| Recall Number | Z-1911-2026 |
| Recall Event ID | 98618 |
| Product Classification | Catheter guide wire kit - Product Code OFB |
| Product | ARROW RADIAL ARTERY CATHETERIZATION KIT |
REF ASK-04220-UCL1
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
REF ASK-04020-EUH2
UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869
REF ASK-04020-FMC
UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870
REF ASK-04020-MMC
UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880
The Arrow Arterial Catheterization Device permits access to the peripheral arterial
circulation or to other small vessels. |
| Code Information | Product code:ASK-04220-UCL1
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
Batch Number: 33F25J0352
Product code: ASK-04020-EUH2
UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869
Batch Number: 33F25J0869
Product code: ASK-04020-FMC
UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870
Batch Number: 33F25J0870
Product code: ASK-04020-MMC
UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880
Batch Number: 33F25J0880 |
| FEI Number | 3013162291 |
| Recalling Firm/
Manufacturer | ARROW INTERNATIONAL, LLC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437 |
| Manufacturer Reason
for Recall | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| FDA Determined
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 | 675 |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. |
| Total Product Life Cycle | TPLC Device Report |
| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |
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