Device product
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278; (01)10887709058757(17)250101(30)100(10)4590919; (01)10887709058757(17)250201(30)100(10)4712217; (01)10887709058757(17)241201(30)100(10)4537440; (01)10887709058757(17)241201(30)100(10)4549906; (01)10887709058757(17)250101(30)100(10)4559515; (01)10887709058757(17)250201(30)100(10)4719743; (01)10887709058757(17)250201(30)100(10)4726897; (01)10887709058757(17)250201(30)100(10)4735597; (01)10887709058757(17)241101(30)100(10)4461205. CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. .
Z-0261-2021
Product summary
- Event
- Event 86054
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total of all products (Listed #1 thru 101) = 304735 units
- Official record key
device-enforcement:Z-0261-2021
Official wording
Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Code information: Lot Numbers:4573278, 4590919, 4712217, 4537440, 4549906, 4559515,4719743, 4726897, 4735597, 4461205.
Distribution pattern: Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
Derived failure modes
-
Manufacturing or process control
manufacturing defect