Home › PUREWAY COMPLIANCE › PureWay®

PureWay®

PUREWAY COMPLIANCE · Model 8 · UDI-DI 10853022008052

MMK

510(k) clearances

979

Adverse events (2 deaths)

Recalls

Facilities

Description

The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 1.2 gallon four pack sharps disposal ship back system (Includes four 1.2 gallon sharps container, box, bag, zip tie)

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

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.