Device product
Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
Z-0250-2021
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-0250-2021
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 Number:4727496.
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