Home › GENEVA HEALTHCARE, LLC › Sewn Tubular Foam Rolls

Sewn Tubular Foam Rolls

GENEVA HEALTHCARE, LLC · Model 40-100-00 · UDI-DI 00810044960587

CCX

510(k) clearances

782

Adverse events (2 deaths)

Recalls

285

Facilities

Description

Sewn Tubular Foam Roll 2" X 72"

Recalls

Date	Firm	Reason
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical 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
2021-07-23	Aspen 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
2021-07-23	Aspen 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
2021-07-23	Aspen 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
2014-05-08	Covidien LLC	Straps may separate from the foam pad.
2011-11-16	Allen Medical Systems, Inc.	C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity
2007-11-27	Allen 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.

Query this across every FDA database — by API.

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

Get your free API key Read the docs

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.