FDA-Device2024-12-11Class II
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
Advanced Medical Solutions Ltd.
Hazard
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Sold states
U.S. Nationwide distribution in the states of IL, TX, and VA.
Affected count
3900 boxes
Manufactured in
Unit A, 33 Road One, Winsford, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0617-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief