Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.
Recalling Firm: Medline Industries, LP
Motif du rappel / Danger
TranslatedMedline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Description du produit & Identification
TranslatedMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.
Produits concernés
TranslatedMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98837 |
| Address 1 | 3 Lakes Dr |
| Code info | Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMH714; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMF179; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25IMI476; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25GME934; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24JMA156; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24IMG162; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23IBG784; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBG512; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBA325; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 26AMK307; Medline SKU DYNJRA0555: UDI/DI 10888277... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260603 |
| Product type | Devices |
| Product quantity | 41720 kits |
| Reason for recall | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260410 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260528 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POI...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Aperçu
- Entreprise responsableMedline Industries, LP
- StatusOngoing
- Niveau de risqueClass I
- DistributionWorldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
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🚨 SAFETY ALERT: Medline Industries, LP - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030. Check if your household is affected: https://therecallfile.com/fr/recalls/medline-kits-containing-huons-co-bupivacaine-hcl-in-dextrose-injection/FDA-Z-2233-2026
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