Medline Industries, LP: 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, Me

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: 30120 kits Lot/code info: Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26ABS354; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25LBC413; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25IBK142; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25FBD584; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25BBK828; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24FBT398; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24BBR608; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23JBB581; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23IBQ010; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23HBM569; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 26AMK346; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25KMG102; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25JMA641; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25GMC349; Medline Kit SKU DYNJRA1154: UD

UPC codes

10889942879236, 40889942879237, 10889942935864, 40889942935865, 10198459155666, 40198459155667, 10888277789838, 40888277789839, 10193489566123, 40193489566124, 10889942802289, 40889942802280, 10889942802272, 40889942802273, 10889942873814, 40889942873815

Source

Official record: FDA (Device enforcement) ↗

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