FDA Enforcement
Class III
Terminated
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Recall: Z-3196-2018
·
Reported September 26, 2018
Enforcement
- Recall Number
- Z-3196-2018
- Event ID
- 80632
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Smiths Medical ASD Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 26, 2018
- Initiation Date
- July 13, 2018
- Classification Date
- September 18, 2018
- Termination Date
- October 19, 2018
- Address
- 6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States
Description
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Reason
The product was mislabeled with the incorrect label.
Code Info
Lot numbers 3306404, 3314069, and 3318698.
Distribution
US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Quantity
29,600 kits