# FDA recall Z-0069-2018

> **Windstone Medical Packaging, Inc.** · Class II · device recall initiated 2017-10-24.

## Product

AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.

## Reason for recall

Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.

## Distribution

US Distribution to the state of : SC

## Key facts

- **Recall number:** Z-0069-2018
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-24
- **Report date:** 2017-11-15
- **Termination date:** 2018-07-02

- **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-0069-2018

## Citation

> AI Analytics. FDA recall Z-0069-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0069-2018. Source: US FDA. Licensed CC0.

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