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STERIS CORPORATION · Model BF388 · UDI-DI 00724995163945

LWG
4
510(k) clearances
36
Adverse events
1
Recalls
59
Facilities

Description

The Hybrid Layer Technology Foot Section Pads are used on STERIS Cmax, 4085, 5085 and 5085SRT Surgical Tables.

Recalls

DateFirmReason
2016-04-19Berchtold Corp.The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-r

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.