Z-0187-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- July 6, 2020
- Termination Date
- May 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total of all products (Listed #1 thru 101) = 304735 units
Product Description
7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051055(17)250101(30)50(10)4590834; (01)10887709051055(17)250101(30)50(10)4557481; (01)10887709051055(17)241201(30)50(10)4536601; (01)10887709051055(17)250201(30)50(10)4724818; (01)10887709051055(17)250201(30)50(10)4733548. 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).
Reason for Recall
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.
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.
Code Information
Lot Numbers:4590834, 4557481, 4536601, 4724818, 4733548.