FDA Medical Device Recalls (openFDA)
Advanced Medical Solutions Ltd.: McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
- Recall number
- Z-0618-2025
- Recalling firm
- Advanced Medical Solutions Ltd.
- Product
- McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
- Status
- Open, Classified
- Initiated
- 2024-10-01
- Posted
- 2024-12-04
- Terminated
- not on file
- Reason
- Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
- 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: Customer.Support@admedsol.com
- Quantity
- 8000 boxes
- Distribution
- U.S. Nationwide distribution in the states of IL, TX, and VA.
- Lot, serial or model codes
- Model Number: 3562 UDI-DI code: 10612479193861 Lot Number: W00070426
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAC
- Firm FEI
- 3003080333
- Firm city
- Winsford
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28