FDA-Device2020-10-28Class II

NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111; (01)10840619060906(17)241201(30)100(10)4493213; (01)10840619060906(17)241201(30)100(10)4510900; (01)10840619060906(17)250301(30)100(10)4749152. Administration sets and their accessories are single use, pre-sterilized devices that provide acc

ICU Medical, Inc.

Hazard

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.

Sold states

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.

Affected count

Total of all products (Listed #1 thru 101) = 304735 units

Manufactured in

951 Calle Amanecer, N/A, San Clemente, CA, United States

Products

NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111; (01)10840619060906(17)241201(30)100(10)4493213; (01)10840619060906(17)241201(30)100(10)4510900; (01)10840619060906(17)250301(30)100(10)4749152. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0263-2021

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief