Glycar SA Pty. recalled 18 units of the SJM Pericardial Patch on October 9, 2025. The affected lot may not meet required tensile strength specifications. Healthcare providers and patients should stop using this device immediately.
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 recall involves the SJM Pericardial Patch, with EnCap Technology, 5x10 cm, Model Number REF C0510. The impacted lot number is T2506245, with an expiration date of May 25, 2028.
The tensile strength of the impacted lot may not meet safety specifications. This failure could lead to device malfunction during surgical procedures, posing significant risks.
There are no reported incidents of injuries or deaths associated with this recall. The product is classified as Class I, indicating a high risk.
Stop using the device immediately. Follow the recall instructions from Glycar SA Pty., Ltd., and contact your healthcare provider for further instructions.
For more information, contact Glycar SA Pty., Ltd. via email. Visit the FDA recall page for additional details.
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