Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
SJM Pericardial Patch Recalled by Glycar SA Pty., Ltd. Due to The impacted lot may not meet the required...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Glycar SA Pty., Ltd. directly.
Affected Products
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Quantity: 18 units
Why Was This Recalled?
The impacted lot may not meet the required tensile strength specification.
Where Was This Sold?
US
About Glycar SA Pty., Ltd.
Glycar SA Pty., Ltd. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report