FDA Device recall Z-0617-2025
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic…
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic… by Advanced Medical Solutions, citing due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0617-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-01 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Advanced Medical Solutions |
| Distribution | US |
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
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Identifiers
| code_info | Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0617-2025%22
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