Device product
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297
Z-2390-2019
Product summary
- Event
- Event 83337
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,679 units
- Official record key
device-enforcement:Z-2390-2019
Official wording
Reason: 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.
Code information: (Lot #, Exp.) REDN2429 9/30/2020; REDN0140 3/31/2020; RECZ1125 7/31/2020; RECX0511 7/31/2020; RECW2477 3/31/2020; RECW1716 3/31/2020; RECW0390 3/31/2020
Distribution pattern: 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,
Derived failure modes
-
Unknown
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.