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Verifine

Promisemed Medical Devices Inc. · Model SSC-005 · UDI-DI 00850011833940

MMK

510(k) clearances

982

Adverse events (2 deaths)

Recalls

Facilities

Description

The Sharps container is single-use, disposable, non-sterile containers intended to be used for health- care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.

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.