NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: 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 4249145, 4254175, 4268512, 4284473, 4310130, 4344873, 4384704, 4397287, 4413719, 4416032, 4436682, 4438637, 4447642, 4447643, 4448692, 4474988, 4477699, 4504970, 4507585, 4548216, 4576444, 4604159, 4612896, 4623259, 4641644, 4642461, 4649980, 4651109, 4654675, 4657004, 4662482, 4666766, 4667313, 4674583, 4675364, 4681741, 4684814, 4690123, 4690865, 4696794, 4697801, 4708269, 4714213, 4719437, 4722836, 4728731, 4742374, 4751087, 4764365, 4771000, 4779457, 4780513, 4790678, 4797308, 4798878, 4809191, 4816855, 4829925.

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