Z-2043-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- May 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 186 units
Product Description
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
Code Information
1) REF ACC010254B: UDI/DI 10193489651683 (each), 40193489651684 (case), Lot Number: 24LDA269; 2) REF ACC010256: UDI/DI 10884389559529 (each), 40884389559520 (case), Lot Number: 24LDA106; 3) REF ACC010316A: UDI/DI 10889942831746 (each), 40889942831747 (case), Lot Number: 24LDA823; 4) REF ACC010389C: UDI/DI 10193489472493 (each), 40193489472494 (case), Lot Number: 24LDB092; 5) REF ACC010627: UDI/DI 10195327226589 (each), 40195327226580 (case), Lot Number: 24LDA268; 6) REF ACC010898: UDI/DI 10198459192074 (each), 40198459192075 (case), Lot Number: 24LDA260.