FDA recall Z-0617-2025

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

Reason for recall

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

Distribution

U.S. Nationwide distribution in the states of IL, TX, and VA.

Key facts

Status

Ongoing

Initiation date

2024-10-01

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winsford, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0617-2025