FDAClass IIApril 29, 2026

Percutaneous Sheath Introducer with 7.5 - 8 Fr. recall

PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿…

Why was Percutaneous Sheath Introducer with 7.5 - 8 Fr. recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130

Product
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿…
Recalling firm
ARROW INTERNATIONAL, LLC
Quantity
115
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Recall date
April 29, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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