Medline anesthesia trays recalled over Huons bupivacaine quality concerns
Medline anesthesia trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 1,100 kits are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
Medline kits containing Huons Co. Bupivacaine HCl in Dextrose Injection, USP, are being recalled. This action covers ANESTHESIA TRAY (Medline SKU DYNJRA1355A) and SPINAL ANESTHESIA TRAY (SKU DYNJRA2151). The action covers 1,100 kits.
The kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, covering the United States nationwide, the US Virgin Islands and other markets. The trays are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the Medline SKUs, UDI codes and lot numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by Medline.
The recalled product
- Product
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,100
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 (10)
- Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each
- FI case
- Lot Numbers: 26CBA272
- Lot Numbers: 26ABS307
- Lot Numbers: 25HBE663
- Lot Numbers: 25FBA408
- Lot Numbers: 25CBG043
- Lot Numbers: 24FBT395
- Medline SKU DYNJRA2151: UDI/DI 10195327365400 each
- Lot Numbers: 24FBT396.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) 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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