5" Appx, Smallbore Trifuse Ext Set w/3 MicroClave" Clear recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709097329(17)250201(30)50(10)4711084. 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).

Where it was distributed

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.

Nationwide AlabamaArizonaCaliforniaColoradoDelawareFloridaGeorgiaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraska