Glycar SA recalls 18 SJM Pericardial Patch with EnCap Technology 5x10 cm distributed in the US to healthcare facilities. The lot may not meet the required tensile strength specification. Stop use and follow manufacturer instructions provided by Glycar and your healthcare provider. Notification was issued by email.
The impacted lot may not meet the required tensile strength specification.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Glycar SA Pty., Ltd. or your healthcare provider for instructions. Notification method: E-Mail
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The SJM Pericardial Patch with EnCap Technology is used in intracardiac repair as a patch material. It is produced by Glycar SA and distributed in the United States to healthcare facilities.
The recall notes the affected lot may not meet the required tensile strength specification, potentially compromising device performance.
This recall is not part of a broader industry pattern.
The recall affects 18 units distributed in the US. There is a risk of device performance issues during surgical use; no injuries have been reported yet.
Recall notice and FDA enforcement page at the provided link. Look for model, lot, and UDI numbers on device labeling and packaging.
Not specified in the notice.
Keep the recall notice, device labeling, sales orders, and correspondence with Glycar SA for records.
Model: REF C0510; Product: SJM Pericardial Patch with EnCap Technology; Size: 5x10 cm; UDI/DI: 05414734007269; Lot Number: T2506245; Expiration: 2028-05-25; Distribution: United States; Quantity: 18 units; Brand: Glycar SA
No injuries or incidents have been reported.
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