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 CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL
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
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 CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);
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: 560074Model Batch Numbers: 0061960383Model 0061972565Model 2. Material: 560214Model Batch Numbers: 0061971346Model 0061977782Model 3. Material: 560272Model Batch Numbers: 0061960367Model 0061971330Model 4. Material: 560327Model Batch Numbers: 0061960420Model 0061977751Model 5. Material: 560394Model Batch Numbers: 0061964747Model 0061976985Model 0061983313Model 6. Material: 560428Model Batch Numbers: 0061976150Model 0061979927Model 7. Material: 560462Model Batch Number: 0061977772Model 8. Material: 560465Model Batch Numbers: 0061976120Model 0061976122Model 0062024615UPC 04046964317873UPC 04046964317859UPC 04046964318061UPC 04046964318054UPC 04046964318108UPC 04046964318085UPC 04046964318221UPC 04046964318207UPC 04046964318429UPC 04046964318405UPC 04046964318610UPC 04046964318597UPC 04046964318764UPC 04046964318740UPC 04046964318801UPC 04046964318788UPC 04046964318948UPC 04046964318931UPC 04046964319136UPC 04046964319112UPC 04046964319273UPC 04046964319259UPC 04046964319440UPC 04046964319426UPC 04046964319471Would you have heard about this one?
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