Huons Bupivacaine Recall: Affected Spinal Trays

Specified BD Whitacre, Quincke, and Sprotte spinal trays are affected when both the product number and finished-good lot match the recall list. Affected BD trays use a remove-and-destroy-the-bupivacaine-ampule correction; affected B. Braun kits must be quarantined and returned; affected Medline kits are quarantined, relabeled, and corrected by removing the component. The cited evidence does not provide an affected Arrow kit list or a Huons lidocaine item-and-lot list.

Enter a maker, tray name, item number, or lot; the lookup returns the supplier-specific action.

The Affected BD Families Are Whitacre, Quincke, and Sprotte

The three BD product families named in the action are:

• BD Spinal Tray with BD Whitacre Needle
• BD Spinal Tray with BD Quincke Needle
• BD Spinal Tray with Sprotte Needle

The affected component is a Huons-manufactured bupivacaine HCl 0.75% with dextrose 8.25%, 2 mL ampule included in specified trays. The family names and drug configuration appear in the BD product notice reproduced by the California Board of Pharmacy.

A family name or product-number match is insufficient. The BD product number and finished-good lot must both match. This prevents quarantining every Whitacre, Quincke, or Sprotte tray and prevents clearing a tray merely because a local inventory description is abbreviated differently.

The broader BD list contains these product numbers: 400866, 400868, 405609, 405621, 405632, 405637, 405645, 405652, 405658, 405671, 405672, 405673, 405674, 405675, 405707, 405709, 405721, 405723, 405735, 405741, and 406704. Their affected lots are reproduced in the lookup from the broader BD recall update.

The published abbreviations have been retained. “WHIT,” “QNKE,” and “SPT” appear to correspond to Whitacre, Quincke, and Sprotte. Product 405709 appears as “WIT,” not “WHIT,” in the reproduced list. The earlier notice also has malformed formatting where the expanded descriptions for 405637 and 405645 meet. The later list clearly supports product 405645, abbreviation “TRAY SPN WHIT22G3.5 L/B-D/E,” and lot B01V223D, but a clean expanded description is not independently available from that earlier row.

The July notice says two lots were added, but its captured text does not preserve the formatting needed to identify those two entries reliably. None of the lookup entries is therefore labeled as newly added.

BD Catalog 405632 Has Two Listed Lots

The individual FDA database record for catalog 405632 describes a BD Spinal Tray with BD Quincke Needle 26 G × 3.5 in. It is recall Z-2250-2026 and lists two affected finished-good lots, each expiring January 1, 2027:

• B01V231D — UDI (01)00382904056322(17)270101(10)B01V231D
• B02V248D — UDI (01)00382904056322(17)270101(10)B02V248D

The identifiers appear in the FDA recall database record for catalog 405632.

The narrow interpretation is:

• 405632 + B01V231D: affected.
• 405632 + B02V248D: affected.
• 405632 + another lot: not established as affected by that individual record.

The last result is not a permanent clearance. It means the combination does not match the captured record and still requires comparison with the latest official list.

Affected BD Trays Keep Their Permitted Remaining Components

For a confirmed BD product-and-lot match, do not use the affected bupivacaine ampule. Remove and destroy it when the tray is opened. The remaining tray components may be used only as permitted by the correction instructions and local procedures.

FDA describes the BD action as a correction rather than removal of every tray from where it is used or sold. It is nevertheless classified as the most serious type. The FDA BD correction notice directs customers to stop using the affected ampules, remove and destroy them when opening the tray, and obtain alternative local bupivacaine.

BD stated that if an affected bupivacaine ampule had already been used without an issue, no additional treatment or clinical follow-up was required. That statement does not address a patient with inadequate anesthesia, suspected infection, inflammation, or another problem. Those cases belong under established clinical escalation, pharmacy, adverse-event, and risk-management procedures.

Physical correction may not close the facility’s administrative work. Local processes may also require quantity reconciliation, destruction records, supplier acknowledgment, relabeling, quarantine updates, and department notification.

B. Braun Kits Must Be Quarantined and Returned

The B. Braun action covers certain products in three families:

• PENCAN Spinal Needle Procedure Kits
• Spinocan Spinal Needle Procedure Kits
• Spinocan Spinal Tray Spinal Needle Anesthesia Procedure Kits

Not every kit in those families is affected. The supplied evidence does not reproduce the complete catalog-number, lot, expiration-date, and UDI list, so staff must use FDA’s full affected-product attachment to compare the kit in hand.

For a confirmed match, stop use and distribution, quarantine the complete kit, and return it to B. Braun. The FDA-listed B. Braun recall contact is recalls@bbraunusa.com or (844) 903-6417. These instructions and contacts appear in the FDA B. Braun notice.

Do not open an affected B. Braun kit and apply BD’s remove-the-ampule procedure. FDA treats the B. Braun action as removal of the specified complete kits.

Medline Kits Use a Separate Component-Removal Correction

Medline’s related correction covers convenience kits containing affected B. Braun components. The named families include anterior hip, C-section, MHCZ total knee, posterior hip, total hip, total joint, and several navigation, no-syringe, basic, and LF configurations.

These are not collectively spinal trays. They include orthopedic, obstetric, and total-joint convenience kits.

For a confirmed Medline match, quarantine and relabel the kit, then remove and discard the affected component before using the remaining contents permitted by the correction. The supplied evidence does not contain every affected Medline item number and lot. Those fields appear as unknown in the lookup rather than being inferred. Confirmation requires the affected-product information linked from the FDA Medline correction notice.

Supplier	Recall Path	Required Handling
BD	Tray correction	Remove and destroy ampule
B. Braun	Whole-kit removal	Quarantine and return kit
Medline	Kit correction	Relabel and discard component

The handling pathways are not interchangeable. A current supplier notice takes precedence if it differs from this routing summary.

Medical Action Models Involve Sodium Chloride, Not Bupivacaine

A separate Medical Action Industries early alert concerns Huons-manufactured sodium chloride ampules, not Huons bupivacaine. The identified epidural-kit models are:

• 82465
• 59553
• 83945B

Only the finished-good lots listed in that separate alert are covered. Those lots were not supplied in the draft evidence and are therefore shown as unknown in the lookup. FDA describes this as an early alert for a potentially high-risk device issue rather than the B. Braun bupivacaine-kit recall. The FDA Medical Action early alert controls that separate workflow.

Do not add these model numbers to the BD bupivacaine list. The shared Huons manufacturer can otherwise create a drug-identification error.

No affected Arrow kit/item/lot data or confirmed Huons lidocaine list appears in the supplied evidence. An Arrow-branded tray, or any kit suspected of containing Huons lidocaine, should not be declared affected or cleared from this article alone. Use the current FDA recall and early-alert index or the manufacturer’s notice.

Manufacturer, Item, and Lot Must Be Checked Together

Start with the supplier printed on the finished tray or kit. Record the catalog, product, item, model, or SKU exactly, including leading zeros and suffixes. Then record the finished-good lot assigned to the complete kit.

Do not substitute a lot printed on a separately stocked component. Do not infer an item number from needle style, tray contents, or appearance.

Compare both identifiers with the current supplier notice. Expiration dates and UDIs can help detect transcription errors when a notice provides them, but they do not replace the manufacturer, product number, and lot comparison.

The notices do not establish one universal label location. Staff may need to examine the product label, shipping case, purchasing record, electronic inventory record, and facility recall documentation. If labeling is damaged, incomplete, or inconsistent with purchasing records, hold the product under facility policy while pharmacy, supply chain, quality, or the supplier resolves the discrepancy.

A precise internal notice should identify the manufacturer, item number, finished-good lot, affected component, and required action. Messages such as “all BD spinal kits” or “all Whitacre trays” are broader than the cited recall.

Reported Risks Differ Between the BD and B. Braun Cohorts

The BD materials connect the action to quality issues identified during an FDA inspection of Huons and limited reports of drug ineffectiveness. Potential risks for affected BD trays include localized infection, inflammatory response, and reduced anesthetic effectiveness.

The BD materials reported no associated serious injuries or deaths as of the FDA notice’s reporting date. The pharmacy-board update stated that no patient harm or product sterility failures had been identified and that BD had not received associated complaints or adverse-event reports.

The B. Braun notice lists infection, inflammatory response, reduced anesthetic effectiveness, cerebrospinal-fluid contamination, meningitis, possible progression to encephalitis, and emergency conversion to general anesthesia. As of April 24, 2026, B. Braun had reported 35 serious injuries and no deaths for its affected cohort.

Those figures cannot be transferred between suppliers. The 35 serious injuries belong to the B. Braun cohort, not the BD spinal trays, and a listed potential harm is not proof that it occurred after every exposure.