Recalls / Class III
Class IIID-0138-2020
Product
Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1188-27.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravascular
- NDC
- 0019-1188
- FDA application
- NDA021569
- Affected lot / code info
- Lots: L159A, Exp. 06/2021; L169A, Exp. 07/2021
Why it was recalled
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Recalling firm
- Firm
- GUERBET LLC
- Manufacturer
- Liebel-Flarsheim Company LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 821 Alexander Rd, Ste 204, 120 W 7th St Suite, Princeton, New Jersey 08540-0000
Distribution
- Quantity
- 3140 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-09-13
- FDA classified
- 2019-10-09
- Posted by FDA
- 2019-10-16
- Terminated
- 2021-10-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0138-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.