Device 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
Z-0617-2025
Product summary
- Event
- Event 95613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3900 boxes
- Official record key
device-enforcement:Z-0617-2025
Official wording
Reason: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Code information: Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134
Distribution pattern: U.S. Nationwide distribution in the states of IL, TX, and VA.
Derived failure modes
-
Sterility assurance
packaging pouch that compromise the device's ability to maintain a sterile