An urgent recall has been announced for a specific lot of SJM Pericardial Patch devices distributed by Glycar SA. Health care professionals using this product should take immediate action to mitigate any risks associated with its continued use. The FDA has identified this recall as its most serious classification, emphasizing the potential risks of serious injury or even death if the affected products are not promptly addressed.
Affected Product Details
The recall pertains to the SJM Pericardial Patch, a medical device used for pericardial closure and cardiac or great vessel reconstruction and repair procedures. The affected units are from lot number T2502257. The distributor, Abbott, and manufacturer, Glycar SA, have already issued communications to affected users, asking for the immediate cessation of use and removal of impacted devices from inventory.
The unique device identifier (UDI) for the affected lot is 05414734007276. This globally recognized system enhances the ability to accurately track medical devices from production to eventual use in clinical settings. Identifying and addressing issues with impacted products is key to maintaining patient safety and preventing adverse outcomes.
Why Was This Recall Issued?
According to the announcement, the recall stems from a quality control deviation found during the manufacturing of lot number T2502257. This deviation specifically relates to the device’s tensile strength, which may fall below required specifications. Such a defect could lead to a postoperative reduction in the mechanical properties of the patch, including potential dehiscence or rupture.
While users would not detect this loss of tensile strength during surgical application, postoperative complications might necessitate reintervention or additional surgical procedures, depending on the initial procedure’s context. To date, Glycar SA has reported no serious injuries or fatalities associated with this issue. However, the potential risks underscore the importance of swiftly addressing the affected devices.
Next Steps for Health Care Professionals
If you possess or utilize the affected lot of SJM Pericardial Patches, it is critical to abide by the manufacturer’s and FDA’s guidelines. Follow these steps:
- Identify and immediately cease the use of any devices from lot number T2502257.
- Quarantine the affected products to ensure they are not used unknowingly.
- Inform all relevant personnel within your institution about this recall notice.
- Coordinate with Abbott, the U.S. distributor for the device, to arrange for the return and replacement of the affected units.
- Complete and return the provided Acknowledgment Form within five business days, confirming receipt and compliance with the recall instructions.
The Role of UDI in Medical Device Safety
The unique device identifier (UDI) system plays an essential role in safeguarding patients and enhancing regulatory oversight. Implementation of UDIs allows for efficient reporting, monitoring, and resolution of adverse events. Health care professionals should leverage resources such as the AccessGUDID database and the FDA’s guidance on recognizing UDIs on medical device labels to support compliance and improve patient outcomes.
The Glycar SA recall highlights the importance of stringent quality control processes in ensuring the safety and efficacy of critical medical devices. By adhering to the recommended steps, clinical teams can help mitigate any potential adverse effects linked to this recall.
Conclusion
The recall of lot number T2502257 of the SJM Pericardial Patch underscores the necessity of maintaining rigorous safeguards in the use of medical devices. Health care and regulatory teams are urged to act immediately to identify and address potentially affected inventory. While no injuries have been linked to the issue at this time, addressing this deviation promptly is vital to ensuring patient safety and reducing operational risks in clinical settings.
Disclaimer
This announcement is intended for informational purposes only. It does not constitute legal or clinical advice. Health care professionals should consult official FDA communications and Glycar SA’s guidance when making decisions related to this recall.