FDA Enforcement
Class II
Ongoing
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
Recall: Z-0617-2025
·
Reported December 11, 2024
Enforcement
- Recall Number
- Z-0617-2025
- Event ID
- 95613
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Advanced Medical Solutions Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 11, 2024
- Initiation Date
- October 1, 2024
- Classification Date
- December 4, 2024
- Address
- Unit A, 33 Road One, Winsford, N/A, United Kingdom
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
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Code Info
Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134
Distribution
U.S. Nationwide distribution in the states of IL, TX, and VA.
Quantity
3900 boxes