FDAFDA · Food and drugs·Recall number Z-0617-2025
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
Published December 11, 2024 · Recall initiated: October 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Medical Solutions Ltd.
- Distributor
- U.S. Nationwide distribution in the states of IL, TX, and VA.
- Lot
- Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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