FDAFDA · Food and drugs·Recall number Z-2380-2019
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874
Published September 4, 2019 · Recall initiated: May 31, 2019
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
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Peripheral Vascular Inc
- Distributor
- US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY OUS: Australia, Canada,
- Lot
- Lot # RECZ0711 Exp. 9/30/2020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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