Guerbet Recalls Sodium Chloride Syringes Due to RFID Formatting Error
Guerbet LLC is recalling 3,140 prefilled sodium chloride syringes because an RFID formatting error prevents the Optivantage injector from administering the product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a technical RFID error preventing administration, not a safety hazard like contamination or injury.
Plain-English summary
Guerbet LLC is recalling 3,140 units of Sodium Chloride Injection USP 0.9% packaged in 125 mL Ultraject Prefilled Syringes. The recall involves lots L159A (exp. 06/2021) and L169A (exp. 07/2021), which were distributed nationwide in the United States. The product is manufactured by Liebel-Flarsheim Company LLC and is intended for intravascular use.
The recall was initiated due to a labeling issue involving an RFID formatting error. This error causes the product to be read as expired by the Optivantage injector, which prevents the injection of the product. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and facilities that have received these specific lots should stop using the affected syringes and contact the recalling firm for instructions on return or disposal. Patients who have already received the product should contact their healthcare provider if they have questions or concerns.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- GUERBET LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 3,140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: L159A
- Exp. 06/2021
- L169A
- Exp. 07/2021
UPCs (1)
- 0300191188816
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GUERBET LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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