Medline Industries, LP: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline

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: 200702 kits Lot/code info: Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 26ABG838; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25JBR222; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25IBJ307; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25EBR346; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 24LDB145; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 24FDB896; Medline Kit SKU DYNJRA0143B: UDI/DI 10195327125820 each, 40195327125821 case, Lot Number 24ABQ670; Medline Kit SKU DYNJRA0205B: UDI/DI 10195327472344 each, 40195327472345 case, Lot Number 24KMD212; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 26CMG585; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 26BMK211; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25JMC385; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25IMB105; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25EMC687; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 24HMD675; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 24HMB249; Medline Kit SKU

UPC codes

10884389459003, 40884389459004, 10195327125820, 40195327125821, 10195327472344, 40195327472345, 10195327282042, 40195327282043, 10884389656778, 40884389656779, 10198459027796, 40198459027797, 10195327253363, 40195327253364, 10195327120689, 40195327120680, 10889942598267, 40889942598268, 10193489432015, 40193489432016, 10888277762947, 40888277762948, 10889942965144, 40889942965145, 10193489566291, 40193489566292, 10193489586732, 40193489586733, 10193489590135, 40193489590136, 10193489658941, 40193489658942, 10195327298692, 40195327298693, 10193489215366, 40193489215367, 10193489422450, 40193489422451, 10193489992427, 40193489992428

Source

Official record: FDA (Device enforcement) ↗

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