Medline spinal block trays recalled over Huons bupivacaine quality concerns
Medline spinal block trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 30,120 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 SPINAL BLOCK TRAY (Medline kit SKU DYNJRA1097), TRAY, SPINAL PENCIL POINT 25G (DYNJRA1154) and SPINAL TRAY, among others listed in the recall notice. The action covers 30,120 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 BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline…
- Manufacturer
- Medline Industries, LP
- Affected units
- 30,120
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 Kit SKU DYNJRA1097: UDI/DI 10889942879236 each
- 40889942879237 case
- Lot Number 26BBJ392
- Lot Number 26ABS354
- Lot Number 25LBC413
- Lot Number 25IBK142
- Lot Number 25FBD584
- Lot Number 25BBK828
- Lot Number 24FBT398
- Lot Number 24BBR608
- Lot Number 23JBB581
- Lot Number 23IBQ010
- Lot Number 23HBM569
- Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each
- 40889942935865 case
- Lot Number 26AMK346
- Lot Number 25KMG102
- Lot Number 25JMA641
- Lot Number 25GMC349
- Lot Number 25DMG474
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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