Class 1 Device Recall SJM

• Date Initiated by Firm: October 09, 2025
• Date Posted: November 25, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0532-2026
• Recall Event ID: 97877
• 510(K)Number: K963967
• Product Classification: Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
• Product: SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Code Information: UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
• Recalling Firm/ Manufacturer: Glycar SA Pty., Ltd.; 1 Albert Road; box 967; Irene South Africa
• Manufacturer Reason for Recall: The impacted lot may not meet the required tensile strength specification.
• FDA Determined Cause: Process control
• Action: Glycar issued a Stock Withdrawal Notification to its sole distributor on 10/09/2025. The notice explained the issue and requested the following: "Required Actions 1. Immediately identify and segregate all affected stock in your possession. 2. Clearly label the identified stock as "WITHDRAWN PRODUCT" DO NOT DISTRIBUTE OR USE. 3. Suspend any further distribution or transfer of the affected lots. 4. Provide written confirmation of the quantity and storage location of all affected stock within five (5) business days of receipt of this notification. 5. Our Quality team will coordinate collection, return, or replacement of affected product as appropriate." For questions or require further clarification, contact: Malcolm Applewhite, malcolm@glycar.co.za On 10/17/2025, the firm issued an URGENT: MEDICAL DEVICE RECALL notice the medical facility via email. This notice explained the issue, potential risk to health, and requested the following: "Actions to be Taken by the Customer / User: 1. Identify and quarantine any affected products with lot number T2502257 in your possession. 2. Cease use of the affected device immediately. 3. Share this notice with applicable personnel within your institution. 4. Abbott will coordinate and arrange for return and replacement of affected units. 5. Complete and return the attached Acknowledgment Form within 5 business days to confirm receipt of this notice." For questions or assistance, contact: Regulatory Affairs Manager, Glycar SA (Pty) Ltd, Malcolm Applewhite, malcolm@glycar.co.za
• Quantity in Commerce: 18 units
• Distribution: US
• 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.

• 510(K) Database: 510(K)s with Product Code = DXZ