PlainRecalls
FDA Devices Moderate 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

Reported: December 11, 2024 Initiated: October 1, 2024 #Z-0617-2025

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

Reason for Recall

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

Details

Units Affected
3900 boxes
Distribution
U.S. Nationwide distribution in the states of IL, TX, and VA.
Location
Winsford

Frequently Asked Questions

What product was recalled?
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. Recalled by Advanced Medical Solutions Ltd.. Units affected: 3900 boxes.
Why was this product recalled?
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0617-2025.