Advanced Medical Solutions product recalled over laceration hazard

Recall date

October 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Advanced Medical Solutions Ltd. recalls Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heav…

Recall number

Z-0617-2025

FDA classification

Class II

Brand / firm

Advanced Medical Solutions Ltd.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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