Medline Spinal Trays Recalled Due to Quality and Efficacy Concerns
Medline Industries is recalling 41,720 spinal anesthesia trays containing Bupivacaine due to quality issues, microbiology testing data integrity concerns, and reported efficacy complaints affecting patient safety.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of medical devices used in invasive procedures with documented data integrity issues and efficacy complaints; while no deaths or hospitalizations are reported, the potential for compromised anesthesia effectiveness poses significant patient safety risk warranting the Class I designation.
Plain-English summary
Medline Industries is recalling 41,720 spinal anesthesia trays containing Bupivacaine Hydrochloride in Dextrose Injection, USP supplied by Huons Co. The affected kits include seven SKU variants and have been distributed worldwide, including throughout the United States, US Virgin Islands, Bahamas, Panama, and Barbados.
The recall was initiated due to quality issues, including documented microbiology testing data integrity concerns and reported efficacy complaints with the Bupivacaine formulation. These issues affect the reliability of anesthetic effectiveness during spinal procedures, creating a potential patient safety risk.
Healthcare providers and medical facilities should identify and quarantine affected lots using the provided SKU numbers and lot codes. Patients who have received spinal anesthesia using these products should contact their healthcare provider if they have questions about the safety or effectiveness of their procedure.
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 T
- Manufacturer
- Medline Industries, LP
- Hazard
- data-integrity
- efficacy-loss
- quality-defect
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
Distributed nationwide across the United States.
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