SJM Pericardial Patch (Glycar) – Tensile Strength Issue (2025)
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
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Brand
Glycar SA Pty., Ltd.
Lot Codes / Batch Numbers
UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128, T2505144, exp. 2028.04.11
Products Sold
UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11
Glycar SA Pty., Ltd. is recalling SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INT due to The impacted lot may not meet the required tensile strength specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The impacted lot may not meet the required tensile strength specification.
Recommended Action
Per FDA guidance
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 Clearly label the identified stock as "WITHDRAWN PRODUCT" DO NOT DISTRIBUTE OR USE. 3.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
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