Medline anesthetic injection kits recalled for quality and efficacy concerns
Medline has recalled 270 bupivacaine injection kits due to microbiology testing data integrity concerns and reported efficacy complaints. The FDA classified this as a Class I recall.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recalls are rated Critical per the regulatory rubric. The quality control issues including microbiology testing data integrity concerns and efficacy complaints in injectable anesthetics present a serious patient safety risk.
Plain-English summary
Medline Industries, LP has recalled 270 kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP manufactured by Huons Co. The recalled products include two specific Medline kit models: SKU DYNJRA1181C and SKU DYNJRA1860.
The recall was initiated due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. These issues create a risk that the medication may not perform as intended for patients requiring regional anesthesia.
The affected kits were distributed worldwide, including nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, and Barbados. The specific lot numbers subject to recall are: 25DMF105 and 25CMB575 for SKU DYNJRA1181C, and 24DMB099 for SKU DYNJRA1860.
The FDA has classified this as a Class I recall, indicating a serious health risk. Healthcare providers who have received or used these kits should consult the FDA's official recall notice and contact Medline Industries for further information and guidance.
The recalled product
- Product
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.
- Manufacturer
- Medline Industries, LP
- Hazard
- quality-failure
- testing-integrity
- efficacy-failure
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 (7)
- Medline Kit SKU DYNJRA1181C: UDI/DI 10193489457605 each
- 40193489457606 case
- Lot Number 25DMF105
- Lot Number 25CMB575
- Medline Kit SKU DYNJRA1860: UDI/DI 10195327008413 each
- 40195327008414 case
- Lot Number 24DMB099.
Distribution
Distributed nationwide across the United States.
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