# FDA recall Z-1202-2022

> **Busse Hospital Disposables, Inc.** · Class II · device recall initiated 2022-02-22.

## Product

Male SS 4.5MM Pellet Insertion Tray    Catalog Number: B9176R1

## Reason for recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1202-2022
- **Recalling firm:** Busse Hospital Disposables, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-22
- **Report date:** 2022-06-08
- **Termination date:** 2024-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hauppauge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2022

## Citation

> AI Analytics. FDA recall Z-1202-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1202-2022. Source: US FDA. Licensed CC0.

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