FDA Medical devices recall ·
Hollister CalciCare Calcium Alginate Dressing recall
- Recall number
- Z-0617-2025
- Date
- (initiated October 1, 2024)
- Company / brand
- Advanced Medical Solutions Ltd.
Unit A, Winsford, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3900 boxes
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134
Distribution
U.S. Nationwide distribution in the states of IL, TX, and VA.
States: Illinois Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0617-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.