# FDA recall Z-0881-2023

> **Windstone Medical Packaging, Inc.** · Class II · device recall initiated 2022-11-01.

## Product

Various Custom Surgical Instrument Disposable Kits:  Part Numbers / Product Description  26000004M	Custom Lasik Kit  AMS10411A	Nasal Endoscopy Pack  AMS10710A	Ultrasound Tray w/PDI  AMS11941	Total Knee Pack  AMS12138B	Eye Pack  AMS12278B	Body Pack  AMS12341A	Hassan Pack  AMS12341B	Hassan Pack  AMS12343A	Meldrum Pack  AMS12359B	Neuro Pack  AMS12520	Total Hip Pack  AMS12608	Extremity Pack  AMS12610	Shoulder Pack  AMS12636	Dr. Thompson Pack  AMS12689A	Custom Pack  AMS12753	Breast Pack  AMS12754	Abdominoplasty Pack  AMS12769	Minor Pack  AMS12926	Shoulder Pack  AMS12927	Retina Pack  AMS13428	Hand Pack  AMS2120D	Plastics Tray  AMS2890(B	Basic Biopsy Tray  AMS3824(A	Myelogram Tray - RX  AMS4022F	Lami Pack  AMS4371C	Lasik Eye Pack  AMS4372	Plastic Eye Pack  AMS4599(C	Spine Pack  AMS4670B	Upper Extremity Pack  AMS4766C	Shoulder Arthroscopy Pack  AMS4952A	Vitrectomy Pack - RX  AMS5697A	EVLT Pack  AMS5819B	Ortho Major Pack  AMS5887A	CARS Pack  AMS6112A	Minor Extremity Pack  AMS6112B	Minor Extremi

## Reason for recall

Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA, CO, CT, FL, Guam, IN, NC, NJ, NV, OK PA, TN, TX, and WI. The country of Canada.

## Key facts

- **Recall number:** Z-0881-2023
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-01
- **Report date:** 2023-01-11

- **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-0881-2023

## Citation

> AI Analytics. FDA recall Z-0881-2023. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0881-2023. Source: US FDA. Licensed CC0.

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