Recall Z-1849-2021— Windstone Medical Packaging, Inc.

Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2021-04-08, terminated 2022-12-15. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld.

Recalling firm

Windstone Medical Packaging, Inc.

Classification

Class II

Status

Terminated

Initiated

2021-04-08

Terminated

2022-12-15

Firm location

Billings, MT, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.