Z-0208-2021 Class II Terminated
FDA device recall Z-0208-2021 was initiated by ICU Medical, Inc. on July 6, 2020 and is designated Class II. 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. The recall status is terminated (terminated May 11, 2023). Affected quantity: Total of all products (Listed #1 thru 101) = 304735 units.
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
Reason for Recall
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.