Arrow Sheath Recall, Class II, Adhesive Issue

Class 2 Device Recall PERCUTANEOUS SHEATH INTRODUCER

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| | Class 2 Device Recall PERCUTANEOUS SHEATH INTRODUCER | |

UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352

The Arrow percutaneous sheath introducer permits venous access and catheter
introduction to the central circulation. |
| Code Information | Product code:ASK-09903-MGH3
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
Batch Number: 33F25K0130 |
| 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 | 115 |
| 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. | |