PlainRecalls
FDA Devices Moderate Class II Terminated

EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881

Reported: September 4, 2019 Initiated: May 31, 2019 #Z-2382-2019

Product Description

EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881

Reason for Recall

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.

Details

Units Affected
100 units
Distribution
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,
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881. Recalled by Bard Peripheral Vascular Inc. Units affected: 100 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 4, 2019. Severity: Moderate. Recall number: Z-2382-2019.