Z-2045-2025 Class II Ongoing
FDA device recall Z-2045-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on May 23, 2025 and is designated Class II. 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, t… The recall status is ongoing. Affected quantity: 80 units.
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
- 80 units
Product Description
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
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 DYNJ0151148B: UDI/DI 10889942050819 (each), 40889942050810 (case), Lot Number 24LDA980