Angio Pack REF: AMS8050A — Class II medical device recall Z-1849-2021

Terminated recall by Windstone Medical Packaging, Inc., reported 2021-06-23, distributed nationwide. Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

Recall number	`Z-1849-2021`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Windstone Medical Packaging, Inc., Billings, MT, United States
Recall initiated	2021-04-08
Classified	2021-06-11
Reported by FDA	2021-06-23
Terminated	2022-12-15
Distributed	Nationwide (US)
Quantity	190 units
Lot numbers	`146305`, `147637`, `148389`, `148814`
Model numbers	`AMS8050A`

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 for recall

Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1849-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.