Class II

Medical Device Recall: 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

Advanced Medical Solutions Ltd. · October 1, 2024

Reason for Recall

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

Product Description

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

3900 boxes

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0617-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Advanced Medical Solutions Ltd. Medical Device Recall: 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 | SafeCheck