FDA Medical devices recall ·
Medline convenience kits containing BD Insyte Autoguard Shielded IV… recall
- Recall number
- Z-2043-2025
- Date
- (initiated May 23, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 186 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
States: California Indiana Kentucky Michigan Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2043-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.