Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (
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
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)
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: 333867Model UDI-DI Primary/Unit of Use: 4046964180842/4046964180835Model Batch Numbers: 0061965993Model 0061968406Model 0061971306Model 0061971487Model 0061978629Model 0061978630Model 2. Material: 333862Model UDI-DI Primary/Unit of Use: 4046964180743/4046964180736Model Batch Numbers: 0061947858Model 0061954126Model 0061970779Model 0061970781Model 0061970783Model 3. Material: 332607Model UDI-DI Primary/Unit of Use: 4046964558757/4046964558740Model Batch Number: 0061976109Model 4. Material: 333868Model UDI-DI Primary/Unit of Use: 4046964180866/4046964180859Model Batch Numbers: 0061958120Model 0061958276Model 0061960474Model 0061960475Model 0061960476UPC 4046964180842UPC 4046964180835UPC 4046964180743UPC 4046964180736UPC 4046964558757UPC 4046964558740UPC 4046964180866UPC 4046964180859UPC 4046964180804UPC 4046964180798UPC 4046964180903UPC 4046964180897UPC 4046964180606UPC 4046964180590Would you have heard about this one?
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