Advanced Medical Solutions Ltd.: Device Recall
Recall #Z-0617-2025 · 10/01/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0617-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Advanced Medical Solutions Ltd.
- Status
- Ongoing
- Date Initiated
- 10/01/2024
- Location
- Winsford, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3900 boxes
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 Pattern
U.S. Nationwide distribution in the states of IL, TX, and VA.
Other Recalls by Advanced Medical Solutions Ltd.
- Class II: Risk 10/01/2024
- Class II: Risk 10/01/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.