Z-2379-2019 Class II Terminated
FDA device recall Z-2379-2019 was initiated by Bard Peripheral Vascular Inc on May 31, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 17, 2022). Affected quantity: 309 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2019
- Initiation Date
- May 31, 2019
- Termination Date
- May 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 309 units
Product Description
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850
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.
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,
Code Information
(Lot #, Exp.) RECZ0638 9/30/2020; RECW0661 7/31/2020