Device product
3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50(10)4579939; (01)10887709087153(17)250101(30)50(10)4592179; (01)10887709087153(17)250101(30)50(10)4610925; (01)10887709087153(17)241201(30)50(10)4547212; (01)10887709087153(17)250101(30)50(10)4712946; (01)10887709087153(17)250201(30)50(10)4720392. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
Z-0224-2021
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-0224-2021
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:4556715, 4579939, 4592179, 4610925, 4547212, 4712946,4720392.
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