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Sharps

PUREWAY COMPLIANCE · Model 1.4 Quart · UDI-DI 00853022008017

MMK

510(k) clearances

979

Adverse events (2 deaths)

Recalls

Facilities

Description

Sharps container: A device designed as a container to allow the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level.

Recalls

Date	Firm	Reason
2006-08-23	Bemis Health Care,Inc	The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.
2006-04-03	EM Innovations Inc	The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers.
2004-02-25	Bemis Manufacturing Co.	The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that wil

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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.