# FDA recall Z-0617-2025

> **Advanced Medical Solutions Ltd.** · Class II · device recall initiated 2024-10-01.

## Product

Hollister CalciCare Calcium Alginate Dressing REF 529937R    calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as:  ¿ pressure ulcers  ¿ leg ulcers  ¿ cavity wounds  ¿ lacerations  ¿ post-operative surgical wounds

## Reason for recall

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

## Distribution

U.S. Nationwide distribution in the states of IL, TX, and VA.

## Key facts

- **Recall number:** Z-0617-2025
- **Recalling firm:** Advanced Medical Solutions Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-01
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Winsford, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0617-2025

## Citation

> AI Analytics. FDA recall Z-0617-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0617-2025. Source: US FDA. Licensed CC0.

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