# FDA recall Z-1849-2021

> **Windstone Medical Packaging, Inc.** · Class II · device recall initiated 2021-04-08.

## 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

## Distribution

US Nationwide distribution in the state of AZ.

## Key facts

- **Recall number:** Z-1849-2021
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-08
- **Report date:** 2021-06-23
- **Termination date:** 2022-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billings, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1849-2021

## Citation

> AI Analytics. FDA recall Z-1849-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1849-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
