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Recall Observatory FDA recall evidence

Device product

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

Z-1910-2026

March 11, 2026

Class II

Product summary

Firm
ARROW INTERNATIONAL, LLC
Event
Event 98618
Status
Ongoing
Classification
Class II
Quantity
85
Official record key
device-enforcement:Z-1910-2026

Official wording

Reason: Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured

Code information: Product code: ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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