Pericardial patches recalled because a lot may not meet tensile strength
Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology 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, 9 x 14 cm, model REF C0914, 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 30 units carrying UDI/DI 05414734007276, from lots T2502257 (expiring 28 January 2028) and T2505144 (expiring 11 April 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 affected lots immediately and follow the firm's instructions.
The recalled product
- Product
- SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; 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 (5)
- UDI/DI 05414734007276
- Lot Numbers: T2502257
- exp. 20280128
- T2505144
- exp. 2028.04.11
Distribution
Distribution scope not specified by the agency.
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