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Positioning Rolls and Bolsters

GENEVA HEALTHCARE, LLC · Model 30-215-00 · UDI-DI 10810044960331

CCX
8
510(k) clearances
782
Adverse events (2 deaths)
7
Recalls
285
Facilities

Description

Small Bolster 18" X 7"

Recalls

DateFirmReason
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2021-07-23Aspen Surgical Products, Inc.Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the
2021-07-23Aspen Surgical Products, Inc.Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the
2021-07-23Aspen Surgical Products, Inc.Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the
2014-05-08Covidien LLCStraps may separate from the foam pad.
2011-11-16Allen Medical Systems, Inc.C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity
2007-11-27Allen Medical Systems, Inc.Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury.

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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.