Medline Industries, LP: 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 DY

Hazard

Medline 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.

Details from the source

Reason for recall: Medline 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. Distribution: Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados. Quantity: 1100 kits Lot/code info: Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26CBA272; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26ABS307; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25HBE663; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25FBA408; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25CBG043; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 24FBT395; Medline SKU DYNJRA2151: UDI/DI 10195327365400 each, FI case, Lot Numbers: 24FBT396.

UPC codes

10195327179830, 10195327365400

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.