EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799
Reported: September 4, 2019 Initiated: May 31, 2019 #Z-2368-2019
Product Description
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799
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
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 34 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 LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799. Recalled by Bard Peripheral Vascular Inc. Units affected: 34 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-2368-2019.
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