Class 2 Device Recall CalciCare Calcium Alginate Dressing

• Date Initiated by Firm: October 01, 2024
• Date Posted: December 04, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0617-2025
• Recall Event ID: 95613
• Product Classification: Dressing, wound, hydrophilic - Product Code NAC
• 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
• Code Information: Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134
• FEI Number: 3003080333
• Recalling Firm/ Manufacturer: Advanced Medical Solutions Ltd.; Unit A; 33 Road One; Winsford United Kingdom
• For Additional Information Contact: James Bartlett; 44 01 606545510
• Manufacturer Reason for Recall: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
• FDA Determined 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 in Commerce: 3900 boxes
• Distribution: U.S. Nationwide distribution in the states of IL, TX, and VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.