Skip to content

Medline Maxorb Extra Alginate Wound Dressing 4x4 Square Ref… recallZ-0619-2025 · Advanced Medical Solutions Ltd. · initiated Oct 1, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Advanced Medical Solutions Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

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]

Recall details

Recall number
Z-0619-2025
Status
Open, Classified
Initiated by the company
Oct 1, 2024
Posted by the FDA
Dec 4, 2024
Recalling firm
Advanced Medical Solutions Ltd.
Quantity
1,800 boxes
Product code
NAC
Distribution
U.S. Nationwide distribution in the states of IL, TX, and VA.

Product description

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.

Code information (models, lots, serial numbers)

Model Number: MSC7044EP UDI-DI code: 10080196296842 Lot Number: W00070789 Model Number: MSC7048EP UDI-DI code: 10080196296828 Lot Number: W00070988

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95613).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page