[pending] SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INT
Pending LLM rewrite. Source: FDA_DEVICE Z-0531-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The impacted lot may not meet the required tensile strength specification.
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 — Devices
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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