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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

GUERBET LLC: Optiray and Sodium Chloride Syringes Recalled for RFID Error

Agency Publication Date: October 7, 2019
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Summary

GUERBET LLC is recalling approximately 7,000 Optiray 320 (ioversol) and Sodium Chloride prefilled syringes used in medical imaging procedures. The recall was initiated because of an electronic RFID formatting error that incorrectly identifies the syringes as expired, preventing the Optivantage power injector from functioning. This issue can cause a delay in necessary medical procedures that require the injection of contrast media or saline.

Risk

The RFID error causes the power injector to block the injection of the product because it incorrectly reads the syringe as past its expiration date. This could result in treatment delays for patients undergoing diagnostic imaging procedures.

What You Should Do

  1. Check your medical supplies for Optiray 320 (ioversol) 320 mg/mL (100 mL syringe) with NDC 0019-1323-00 and lot numbers L141C, L162A (Exp. 06/2021) or L146DS (Exp. 05/2021).
  2. Check your medical supplies for Sodium Chloride Injection USP 0.9% (125 mL syringe) with NDC 0019-1188-27 and lot numbers L159A (Exp. 06/2021) or L169A (Exp. 07/2021).
  3. Contact your healthcare provider or pharmacist for guidance regarding the use of these syringes in scheduled procedures.
  4. Return any unused affected syringes to the place of purchase for a refund and contact GUERBET LLC at their Princeton, NJ location for further instructions.
  5. For additional questions or to report issues, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Optiray 320 (ioversol) Injection 68%, 320 mg/mL (100 mL Ultraject Prefilled Syringe)
Model:
NDC 0019-1323-00
Recall #: D-0137-2020
Lot Numbers:
L141C (Exp. 06/2021)
L162A (Exp. 06/2021)
L146DS (Exp. 05/2021)
Date Ranges: May 2021, June 2021
Product: Sodium Chloride Injection USP 0.9% (125 mL Ultraject Prefilled Syringe)
Model:
NDC 0019-1188-27
Recall #: D-0138-2020
Lot Numbers:
L159A (Exp. 06/2021)
L169A (Exp. 07/2021)
Date Ranges: June 2021, July 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83798
Status: Resolved
Manufacturer: GUERBET LLC
Sold By: Authorized distributors; Medical facilities
Manufactured In: United States
Units Affected: 2 products (3860 syringes; 3140 syringes)
Distributed To: Nationwide
Agency Last Updated: October 9, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.