Bemis Two Gallon Sharps Container

• • Terminated Z-0789-04 FDA Unclassified (pre-2012) ·initiated 25 Feb 2004 ·on shared 510(k) K965248

  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 will not fit into the designated slot because the slot is occluded with plastic.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K965248 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K852335 Active Cleared 16 Sep 1985

• Bemis One Quart Phlebotomy Container (Part Number 100)

  Class II

  FDA 510(k) K960525 Active Cleared 28 Mar 1996

• Suction Connecting Tubing

  Class II

  FDA 510(k) K914601 Active Cleared 7 Feb 1992

• No-Pokes Needle Safety Device

  Class II

  FDA 510(k) K020921 Active Cleared 11 Jul 2002

• Sharps Disposal Container/Phlebotomy

  Class II

  FDA 510(k) K941665 Active Cleared 23 May 1994

• Sharp Disposal Containers Wall Safe

  Class II

  FDA 510(k) K941664 Active Cleared 23 May 1994

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