FDAFDA · Food and drugs·Recall number Z-2658-2018
120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Published August 15, 2018 · Recall initiated: July 31, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
- Lot
- Item Number Z4089, Lot Number 69-717-SJ, 70-260-SL, 73-197-HE, 74-725-JW
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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