FDAClass IIDecember 11, 2024

Hollister CalciCare Calcium Alginate Dressing recall: Sterility Concern

Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute…

Why was Hollister CalciCare Calcium Alginate Dressing recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134

Product
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute…
Recalling firm
Advanced Medical Solutions Ltd.
Quantity
3900 boxes
Distribution
U.S. Nationwide distribution in the states of IL, TX, and VA.
Recall date
December 11, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls