Medline spinal trays recalled over Huons bupivacaine quality concerns
Medline spinal trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled over microbiology data integrity and efficacy complaints.
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 SPINAL TRAY W/PENCIL POINT NDL (Medline kit SKUs DYNJRA0245 and DYNJRA0555) and SPINAL TRAY, among others listed in the recall notice. The action covers 41,720 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) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL…
- Manufacturer
- Medline Industries, LP
- Affected units
- 41,720
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 (20)
- Medline SKU DYNJRA0245: UDI/DI 10884389573488 each
- 40884389573489 case
- Lot Number 26AMH714
- Lot Number 26AMF179
- Lot Number 25IMI476
- Lot Number 25GME934
- Lot Number 24JMA156
- Lot Number 24IMG162
- Lot Number 23IBG784
- Lot Number 23HBG512
- Lot Number 23HBA325
- Medline SKU DYNJRA0555: UDI/DI 10888277270923 each
- 40888277270924 case
- Lot Number 26AMK307
- Lot Number 25LME383
- Lot Number 25JMJ632
- Lot Number 25IMI508
- Lot Number 25IMB093
- Lot Number 25GMB270
- Lot Number 25EMD040
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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