Z-0617-2025Class II

Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for...

Name: Z-0617-2025 Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for...
Creator: Advanced Medical Solutions Ltd.
Published: 2024-10-01
License: https://open.fda.gov/license/

Advanced Medical Solutions Limited / initiated 2024-10-01 / Open, Classified / root cause: packaging

FDA source

Advanced Medical Solutions Ltd. began a recall of Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds... on 2024-10-01. FDA classified it as Class II and gives the reason as "Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0617-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-01
Posted: 2024-12-04
Recalling firm: Advanced Medical Solutions Limited
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
Product code: NAC Dressing, Wound, Hydrophilic
Reason for recall: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 10/22/2024, the firm emailed a "Field Corrective Action - Field Notice" to customers. On 11/19/2024, an "URGENT: MEDICAL DEVICE RECALL" Letter was distributed via email to affected customers informing them that the firm has become aware of defects on primary packaging pouches, in which minor missing patches of Polyethylene have been detected. These defects could compromise the device's ability to maintain a sterile barrier. Customers are instructed: Distributor/Logistic Centers - 1. Stop/cease distribution of affected products. Immediately inspect internal inventory for the aforementioned packaging defect and quarantine all affected Product pending safe destruction. 2. As soon as possible, and no later than 14 days after receipt of this Recall Notice, complete the attached APPENDIX 1 - DISTRIBUTOR / LOGISTIC CENTRES FORM and return it to AMS by post or by email. 3. As soon as possible, and no later than 14 days after receipt of this Recall Notice, complete the attached APPENDIX 3 - CERTIFICATE OF DESTRUCTION FORM and return it to AMS by post or by email. 4. Immediately distribute this Recall Notice to all affected end user customers/Healthcare facilities alongside the attached APPENDIX 2 - CUSTOMER REPLY FORM and APPENDIX 3 - CERTIFICATE OF DESTRUCTION . Advise them to execute the actions and collect the forms from customers. 5. END USERS Ensure product is inspected at point of care in line with the aforementioned packaging defect and execute actions in accordance with this Notice 6. The Recall Notice does not need to be communicated to patients. There is no action to take with patients. 7. Relevant product that has passed inspection without defect presence can be removed from quarantine and returned to distribution. 8. Defect product will be replaced free of charge upon receipt of certificate of destruction (Appendix 3). 9. Customer Services Contact Number: +44 1606 545617 Email: [email protected]
Quantity in commerce: 3900 boxes
Distribution: U.S. Nationwide distribution in the states of IL, TX, and VA.
Product codes and lots: Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0617-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0617-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0618-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04
Z-0619-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04

Product code NAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)