Recall Z-2208-2020
Bard Peripheral Vascular Inc · initiated June 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
Codes / lots: LOT RECV3572
Reason for recall
Incorrect Peel-Apart Introducer Sheath in Kit.
FDA-determined 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.
Details
- Recall number
- Z-2208-2020
- Initiated
- June 14, 2019
- Terminated
- September 18, 2024
- Product code
- MSD – Catheter, Hemodialysis, Implanted
- Quantity
- 215
- 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.
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2209-2020 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16FIncorrect Peel-Apart Introducer Sheath in Kit. | 06/14/2019Terminated |