Recall Z-0617-2025— Advanced Medical Solutions Ltd.
Class II · Ongoing
Class II FDA medical device recall by Advanced Medical Solutions Ltd., initiated 2024-10-01. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Advanced Medical Solutions Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-01
- Firm location
- Winsford, United Kingdom
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
Reason for recall
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.