Medline Maxorb Extra Alginate Dressing (Advanced Medical) – Packaging Sterility Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
Brand
Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988
Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom is recalling MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE due to Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026