Healix Recalls Bupivacaine HCl Bags Due to Particulate Matter
Healix Infusion Therapy is recalling 10 bags of BUPivacaine HCl 0.25% in On-Q C-bloc bags distributed in Texas due to visible particles.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Healix Infusion Therapy, Inc. is recalling 10 bags of BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bags. The affected product is identified by Lot # 6156-0 and an expiration date of 03/07/14. The product was distributed in Texas.
The recall was initiated because the bupivacaine HCl injection used to compound this specific lot was recalled by the supplier. This action followed a customer complaint regarding visible particles embedded in the glass vial of the source material.
Consumers and healthcare providers should stop using the affected product and contact Healix Infusion Therapy, Inc. for further instructions or a return.
The recalled product
- Product
- BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.
- Manufacturer
- Healix Infusion Therapy, Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 10
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 (2)
- Lot #: 6156-0
- Exp 03/07/14
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Healix Infusion Therapy, Inc.
See all →- SevereHealix Recalls Fentanyl Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SevereHealix Recalls Fentanyl Syringes Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SevereHealix Recalls Fentanyl Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SevereHealix Recalls Fentanyl Syringes Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SevereHealix Recalls Fentanyl and Ropivacaine Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- SevereHealix Recalls Fentanyl and Ropivacaine Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SeverePharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulates
FDA (Drugs) · 2016-07-27
- SeverePharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate
FDA (Drugs) · 2016-07-27
- SeverePharmedium Recalls Bupivacaine HCl Bags Due to Glass Particulate Matter
FDA (Drugs) · 2016-07-27
- SevereHealix Recalls Fentanyl Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SeverePharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
FDA (Drugs) · 2016-07-27