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Recall Observatory FDA recall evidence

Device product

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665

Z-2044-2025

May 23, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 97027
Status
Ongoing
Classification
Class II
Quantity
36 units
Official record key
device-enforcement:Z-2044-2025

Official wording

Reason: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

Code information: 1) REF ACC010665: UDI/DI 10195327334918 (each), 40195327334919 (case), Lot Number 24LDA590

Distribution pattern: US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.