Medline Industries, LP: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline K

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: 28106 kits Lot/code info: Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA724; Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA306; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMH667; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMC856; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMA370; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25IMI402; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25HME985; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25AMI063; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMI488; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMA113; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 23KMD776; Medline SKU DYNJRA1920: UDI/DI 10195327111168 each, 40195327111169 case, Lot Numbers: 25FBQ144; Medline SKU DYNJRA2013: UDI/DI 10195327212049 each, 40195327212040 case, Lot Numbers: 26ABV382; Medline SKU DYNJRA2013: UDI/DI 10195327212049 each, 40195327212040 case, Lot Numbers: 24GBA206; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 26BMJ305; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327

UPC codes

10193489238723, 40193489238724, 10193489942354, 40193489942355, 10195327111168, 40195327111169, 10195327212049, 40195327212040, 10195327217402, 40195327217403, 10195327269142, 40195327269143, 10198459371967, 40198459371968, 10195327296797, 40195327296798, 10198459009273, 40198459009274, 10195327332334, 40195327332335, 10198459699856, 40198459699857, 10195327356255, 40195327356256, 10195327428174, 40195327428175, 10195327572686, 40195327572687, 10195327675981, 40195327675982, 10198459003448, 40198459003449, 10198459006401, 40198459006402, 10198459342363, 40198459342364, 10198459660931, 40198459660932, 10198459048043, 40198459048044

Source

Official record: FDA (Device enforcement) ↗

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