# FDA recall Z-1848-2021

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

## Product

Angio Pack  REF: AMS6908C, Sterile EO, Contents:1	Blade Scalpel # 11 SS  1	Bowl Guidewire 80 oz  4	Clamp Towel 2.5  1	Cover Probe 6X48 NS  2	Gown Surgical STD XLG NR  16	Label Custom  1	Counter Needle Nest  40	Sponge 4x4x12 plain  1	Syringe 10cc control polyc  1	Bag Band Dome 22  2	Prep ChloraPrep One-Step 3  1	Dressing Transparent 4 X 4  1	Glove Perry 6.5 PF Steril  1	Bowl Fluid Containment W/Li  1	Cover backtable 50 X 90 Zon  1	Cup medicine 2 oz clear  2	Stopcock 3 way rot m/l/l   2	Needle RB 22x 1.5  1	Spike Bag decanter  6	Syringe 10cc L/L  10	Towel or Blue  2	Bag Band 36 X 50 W/TP  1	Prep Ultra Sound Gel Packet  1	Bowl Denture Cup 8 oz (250C  1	Bowl 32 oz (1000CC)  1	Cover Set UP 54X90  1	Instr Forcep Kelly Strt 5.5  1	Angio Tubing HP 10 W/ROT M/L  1	Needle Introducer 21G  1	Dressing Telfa 3X4  2	Syringe 20cC L/L  1	Guidewire Nitinol .018X45CM  1	Drape Angio 80 X 125 W/2 WIN  1	Introducer 5F X 10CM Stiff.

## 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-1848-2021
- **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-1848-2021

## Citation

> AI Analytics. FDA recall Z-1848-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1848-2021. Source: US FDA. Licensed CC0.

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