SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
This recall is currently active, issued November 25, 2025. It was issued by Glycar Sa Pty., Ltd..
- Company
- Glycar Sa Pty., Ltd.
- Recall Initiated
- October 9, 2025
- Posted
- November 25, 2025
- Recall Number
- Z-0532-2026
- Quantity
- 18 units
- Firm Location
- Irene South Africa
- Official Source
- View on FDA website ↗
Reason for Recall
The impacted lot may not meet the required tensile strength specification.
Distribution
US
Lot / Code Info
UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
Root Cause
Process control
Action Taken
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 Clearly label the identified stock as "WITHDRAWN PRODUCT" DO NOT DISTRIBUTE OR USE. 3.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