Device product
Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3
Z-1849-2021
Product summary
- Event
- Event 87859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190 units
- Official record key
device-enforcement:Z-1849-2021
Official wording
Reason: Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Code information: Lot Number 146305, 147637, 148389, and 148814
Distribution pattern: US Nationwide distribution in the state of AZ.
Derived failure modes
-
Unknown
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld