B Braun Medical Inc: Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL

Hazard

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

Details from the source

Reason for recall: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. Distribution: US Nationwide distribution. Quantity: 104,720 units Lot/code info: 1. Material: 560074; UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859; Batch Numbers: 0061960383, 0061972565; 2. Material: 560214; UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054; Batch Numbers: 0061971346, 0061977782; 3. Material: 560272; UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085; Batch Numbers: 0061960367, 0061971330; 4. Material: 560327; UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207; Batch Numbers: 0061960420, 0061977751; 5. Material: 560394; UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405; Batch Numbers: 0061964747, 0061976985, 0061983313; 6. Material: 560428; UDI-DI Primary/Individual Unit of Use: 04046964318610/04046964318597; Batch Numbers: 0061976150, 0061979927; 7. Material: 560462; UDI-DI Primary/Individual Unit of Use: 04046964318764/04046964318740; Batch Number: 0061977772; 8. Material: 560465; UDI-DI Primary/Individual Unit of Use: 04046964318801/04046964318788; Batch Numbers: 0061976120, 0061976122, 0062024615; 9. Material: 560476; UDI-DI Primary/Individual Unit of Use: 04046964318948/04046964318931; Batch Numbers: 0061964879, 0061977776, 0061985361; 10. Material: 560497; UDI-DI Primary/Individual Unit of Use: 04046964319136/04046964319112; Batch Numbers: 0061967077, 0061985362; 11. Material: 560513; UDI-DI Primary/Individual Unit of Use: 04046964319273/04046964319259; Batch Numbers: 0061961836, 0061977766; 12. Material: 560521; UDI-DI Primary/Individu

UPC codes

04046964317873, 04046964317859, 04046964318061, 04046964318054, 04046964318108, 04046964318085, 04046964318221, 04046964318207, 04046964318429, 04046964318405, 04046964318610, 04046964318597, 04046964318764, 04046964318740, 04046964318801, 04046964318788, 04046964318948, 04046964318931, 04046964319136, 04046964319112, 04046964319273, 04046964319259, 04046964319440, 04046964319426, 04046964319471, 04046964319457, 04046964319518, 04046964319495, 04046964319587, 04046964319563, 04046964319990, 04046964319976, 04046964320194, 04046964320170, 04046964320293, 04046964320286, 04046964320408, 04046964320378, 04046964320842, 04046964320828

Source

Official record: FDA (Device enforcement) ↗

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