Smaller pericardial patches recalled over a tensile strength specification failure
Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The SJM Pericardial Patch with EnCap Technology, 5 x 10 cm, model REF C0510, from Glycar SA, is being recalled. The product is an intracardiac patch and pledget material.
The impacted lot may not meet the required tensile strength specification.
The recall covers 18 units carrying UDI/DI 05414734007269, from lot T2506245, expiring 25 May 2028. The product was distributed in the United States.
The FDA has classified this as a Class I recall, its most serious category, used where there is a reasonable probability of serious injury or death. A cardiac patch that falls short of its tensile strength specification is load-bearing once implanted.
Facilities should quarantine the affected lot immediately and follow the firm's instructions.
The recalled product
- Product
- SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
- Manufacturer
- Glycar SA Pty., Ltd.
- Category
- Medical Device — Cardiac implant
- Hazard
- tensile-strength
- specification-failure
- class-i
- implant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 05414734007269
- Lot Number T2506245
- exp. 2028.05.25
Distribution
Distribution scope not specified by the agency.
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