Recall Z-2002-2020
ICU Medical, Inc. · initiated January 2, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01
Codes / lots: LOT Number/ UDI - 4350491/0 0840619 03011 7
Reason for recall
Inability for the guidewire to pass through the needles included with the catheter kits.
FDA-determined cause: Process control
Action taken
The firm has contracted Stericycle, Inc., Indianapolis, IN for customer notification, response tracking and effectiveness check. On 02 January 2020, Stericycle, Inc. sent URGENT: MEDICAL DEVICE RECALL notification of the market action to the firm's direct consignees of record.
Details
- Recall number
- Z-2002-2020
- Initiated
- January 2, 2020
- Terminated
- September 14, 2022
- Product code
- DQE – Catheter, Oximeter, Fiber-Optic
- Quantity
- 15
- Distribution
- US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.
- Recalling firm
- ICU Medical, Inc., San Clemente, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1996-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | 01/02/2020Terminated |
| Z-1997-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | 01/02/2020Terminated |
| Z-1998-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | 01/02/2020Terminated |
| Z-1999-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | 01/02/2020Terminated |
| Z-2000-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | 01/02/2020Terminated |
| Z-2001-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | 01/02/2020Terminated |