Recalls / —
—#181124
Product
EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
- FDA product code
- MSD — Catheter, Hemodialysis, Implanted
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K090901
- Affected lot / code info
- LOT RECV3572
Why it was recalled
Incorrect Peel-Apart Introducer Sheath in Kit.
Root cause (FDA determination)
Error in labeling
Action the firm took
On 06/14/2019, an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to each of the US consignees via FedEx with proof of delivery notification.
Recalling firm
- Firm
- Bard Peripheral Vascular Inc
- Address
- 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438
Distribution
- Distribution pattern
- 67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.
Timeline
- Recall initiated
- 2019-06-14
- Terminated
- 2024-09-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #181124. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.