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ELITE

STERIS CORPORATION · Model BF482 · UDI-DI 00724995219871

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

Description

ELITE Flat Bottom Chest Roll 16X6X4 is used for prone and lateral postures and may be used in conjunction with the Prone Positioner (BF485) and Prone Headrest (BF464 large/BF465 medium).

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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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.