BEUDAMED
    FDA Enforcement Class I Ongoing

    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)

    Recall: Z-2276-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2276-2026
    Event ID
    98838
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    June 10, 2026
    Initiation Date
    May 6, 2026
    Classification Date
    June 3, 2026
    Address
    824 12th Ave, Bethlehem, PA, 18018-3524, United States

    Description

    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)

    Reason

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

    Code Info

    1. Material: 333867; UDI-DI Primary/Unit of Use: 4046964180842/4046964180835; Batch Numbers: 0061965993, 0061968406, 0061971306, 0061971487, 0061978629, 0061978630; 2. Material: 333862; UDI-DI Primary/Unit of Use: 4046964180743/4046964180736; Batch Numbers: 0061947858, 0061954126, 0061970779, 0061970781, 0061970783; 3. Material: 332607; UDI-DI Primary/Unit of Use: 4046964558757/4046964558740; Batch Number: 0061976109; 4. Material: 333868; UDI-DI Primary/Unit of Use: 4046964180866/4046964180859; Batch Numbers: 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, 0061970726, 0061970727, 0061970729, 0061970730, 0061971108, 0061975011, 0061975012, 0061975013, 0061975014, 0061975015, 0061975016, 0061975017, 0061975018, 0061976996, 0061976997, 0061976998, 0061976999, 0061979852; 5. Material: 333865; UDI-DI Primary/Unit of Use: 4046964180804/4046964180798; Batch Numbers: 0061952152, 0061964964, 0061968295; 6. Material: 333871; UDI-DI Primary/Unit of Use: 4046964180903/4046964180897; Batch Number: 0061954099; 7. Material: 333851; UDI-DI Primary/Unit of Use: 4046964180606/4046964180590; Batch Numbers: 0061954106, 0061954107, 0061954108, 0061954123, 0061954124, 0061954125, 0061954130, 0061954131, 0061954132, 0061954134, 0061954135, 0061960457, 0061960458, 0061960459, 0061960460, 0061960461, 0061965687, 0061965688, 0061965689, 0061967621, 0061967623, 0061967624, 0061967626, 0061969508, 0061969986, 0061970102, 0061970104, 0061970105, 0061970106, 0061970107, 0061970109, 0061970110, 0061970860, 0061970861, 0061970863, 0061970864, 0061970866, 0061970867, 0061971261, 0061971262, 0061971263, 0061971264, 0061971265, 0061971266, 0061971268, 0061971269, 0061972812, 0061972813, 0061974198, 0061974199, 0061974200, 0061974201, 0061974247, 0061974248, 0061974249, 0061974250, 0061974251, 0061974253, 0061974559, 0061974562, 0061974563, 0061974564, 0061974569, 0061975004, 0061975005, 0061975006, 0061975007, 0061975008, 0061975009, 0061975810, 0061976903, 0061976904, 0061976905, 0061976906, 0061976908, 0061976909, 0061976910, 0061976911, 0061976912, 0061976913, 0061976914, 0061976915, 0061979785, 0061979786, 0061979787, 0061979788, 0061979790, 0061979791, 0062019490;

    Distribution

    US Nationwide distribution.

    Quantity

    582,030 units