PlainRecalls
FDA Devices Moderate Class II Terminated

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303

Reported: September 4, 2019 Initiated: May 31, 2019 #Z-2391-2019

Product Description

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303

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
899 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?
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303. Recalled by Bard Peripheral Vascular Inc. Units affected: 899 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-2391-2019.