NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Reason: The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.

Code information: Lots 4252270, 4258403, 4267307, 4286293, 4296386, 4305398, 4312787, 4319281, 4336401, 4343385, 4352284, 4370385, 4417683, 4427096, 4436520, 4439649, 4445172, 4455645, 4469281, 4474769, 4483300, 4491492, 4501007, 4504388, 4526037, 4534521, 4548004, 4556186, 4563246, 4572198, 4579885, 4589493, 4596981, 4602977, 4610952, 4615163, 4635832, 4640945, 4641157, 4643773, 4644633, 4645742, 4647216, 4651057, 4652077, 4653026, 4654115, 4656506, 4659419, 4661293, 4666038, 4669620, 4672305, 4675911, 4677125, 4678565, 4680094, 4683383, 4687490, 4691906, 4699478, 4701150, 4705865, 4707039, 4713618, 4717093, 4721008, 4721703, 4728322, 4734590, 4737996, 4747095, 4752736, 4755523, 4758049, 4761399, 4769406, 4773514, 4775480, 4778540, 4782788, 4789727, 4792459, 4792513, 4794949, 4799221, 4800287, 4805516, 4808480, 4811203, 4813943, 4820909, 4829858, 4832192, 4833848, 4834156.

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.