# FDA recall Z-1228-2022

> **BSN Medical Inc** · Class II · device recall initiated 2022-02-01.

## Product

(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box.  Shipping case contains 10 folding boxes.    (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box.  Shipping case contains 10 folding boxes.

## Reason for recall

The folding boxes within the shipping case are mislabeled.  The shipping case and immediate packages within the folding boxes are correctly labeled.

## Distribution

US Nationwide distribution in the states of AZ, FL, CA, IL, KS, MA, MN, MO, NC, NH, OH, PA, TX, VA, and WA.  There was no foreign/government/military distribution.

## Key facts

- **Recall number:** Z-1228-2022
- **Recalling firm:** BSN Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-01
- **Report date:** 2022-06-15
- **Termination date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Charlotte, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1228-2022

## Citation

> AI Analytics. FDA recall Z-1228-2022. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1228-2022. Source: US FDA. Licensed CC0.

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