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MEDICAL DEVICE RECALLCRITICAL
Pencan Spinal Needle Trays
B. Braun recalls Pencan spinal needle trays over potential quality issues with bupivacaine component.
What to do
Check your inventory for the affected material numbers (333867, 333862, 332607, 333868, 333865, 333871, 333851) and discontinue use immediately. Contact B. Braun Medical for instructions on returning the product and obtaining a replacement.
Why it was recalled
B. Braun Medical is recalling Pencan spinal needle procedure kits due to potential quality issues with the Bupivacaine Hydrochloride in Dextrose Injection component, which may affect drug delivery. The affected kits include various 24G and 25G spinal trays with bupivacaine and dextrose.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| 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) | – | Z-2277-2026 | 4046964179365, 4046964179358, 0061976152, 4046964179389, 4046964179372, 0061965729, 0061971323, 0061972572, 4046964179488, 4046964179471, 0061978177 |
| 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) | – | Z-2276-2026 | 4046964180842, 4046964180835, 0061965993, 0061968406, 0061971306, 0061971487, 0061978629, 0061978630, 4046964180743, 4046964180736, 0061947858, 0061954126, 0061970779, 0061970781, 0061970783, 4046964558757, 4046964558740, 0061976109, 4046964180866, 4046964180859 |
| 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 ( | – | Z-2278-2026 | 04046964317873, 04046964317859, 0061960383, 0061972565, 04046964318061, 04046964318054, 0061971346, 0061977782, 04046964318108, 04046964318085, 0061960367, 0061971330, 04046964318221, 04046964318207, 0061960420, 0061977751, 04046964318429, 04046964318405, 0061964747, 0061976985 |
| 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); | 0061960383, 0061972565, 0061971346, 0061977782, 0061960367, 0061971330, 0061960420, 0061977751, 0061964747, 0061976985, 0061983313, 0061976150, 0061979927, 0061977772, 0061976120, 0061976122, 0062024615, 0061964879, 0061977776, 0061985361, 0061967077, 0061985362, 0061961836, 0061977766, 0061967083, 0061977226, 0061952176, 0061971321, 0061954120, 0061971287, 0061971288, 0061971325, 0061973771, 0061961001, 0061967090, 0061961847, 0061972579, 0061951279, 0061954147, 0061958274 (+39 more, see the official notice) | – | 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 (+30 more, see the official notice) |
| Spinocan Spinal Needle procedure kits | 0061976152, 0061965729, 0061971323, 0061972572, 0061978177 | – | 4046964179365, 4046964179358, 4046964179389, 4046964179372, 4046964179488, 4046964179471 |
| Spinal Needle procedure kits | 0061965993, 0061968406, 0061971306, 0061971487, 0061978629, 0061978630, 0061947858, 0061954126, 0061970779, 0061970781, 0061970783, 0061976109, 0061958120, 0061958276, 0061960474, 0061960475, 0061960476, 0061960477, 0061960478, 0061965732, 0061965733, 0061965734, 0061965735, 0061965736, 0061965737, 0061965738, 0061965739, 0061965740, 0061965741, 0061965743, 0061969393, 0061969394, 0061969395, 0061969397, 0061969438, 0061969439, 0061969440, 0061969441, 0061970674, 0061970675 (+111 more, see the official notice) | – | 4046964180842, 4046964180835, 4046964180743, 4046964180736, 4046964558757, 4046964558740, 4046964180866, 4046964180859, 4046964180804, 4046964180798, 4046964180903, 4046964180897, 4046964180606, 4046964180590 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from B Braun Medical Inc
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification