Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (
B Braun Medical Inc
The 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. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. Material: 333201Model UDI-DI Primary/Unit of Use: 4046964179365/4046964179358Model Batch Number: 0061976152Model 2. Material: 333211Model UDI-DI Primary/Unit of Use: 4046964179389/4046964179372Model Batch numbers: 0061965729Model 0061971323Model 0061972572Model 3. Material: 333231Model UDI-DI Primary/Unit of Use: 4046964179488/4046964179471Model Batch Number: 0061978177UPC 4046964179365UPC 4046964179358UPC 4046964179389UPC 4046964179372UPC 4046964179488UPC 4046964179471Would you have heard about this one?
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