Device product
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Z-2045-2025
Product summary
- Event
- Event 97027
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80 units
- Official record key
device-enforcement:Z-2045-2025
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 DYNJ0151148B: UDI/DI 10889942050819 (each), 40889942050810 (case), Lot Number 24LDA980
Distribution pattern: US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
Derived failure modes
-
Unknown
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.