Z-1849-2021 Class II Terminated
FDA device recall Z-1849-2021 was initiated by Windstone Medical Packaging, Inc. on April 8, 2021 and is designated Class II. Reason for recall: Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld The recall status is terminated (terminated December 15, 2022). Affected quantity: 190 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- April 8, 2021
- Termination Date
- December 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
Product Description
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
Reason for Recall
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Distribution Pattern
US Nationwide distribution in the state of AZ.
Code Information
Lot Number 146305, 147637, 148389, and 148814