EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
This recall has been terminated (originally issued June 14, 2019).
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- June 14, 2019
- Terminated
- September 18, 2024
- Recall Number
- Z-2209-2020
- Quantity
- 400
- Firm Location
- Tempe, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect Peel-Apart Introducer Sheath in Kit.
Distribution
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.
Lot / Code Info
RECT0999
Root Cause
Error in labeling
Action Taken
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.
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