Z-1912-2026Class II

ARROW INTERNATIONAL, LLC

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-04-29

Distribution

U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Firm state

Product quantity

115

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

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

Product description

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¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control

2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIFayus Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.

See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.