Z-2534-2026Class II
Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-05-21 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL... on . FDA classified it as Class II and gives the reason as "The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2534-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147
- Product code
- OFT Spinal Epidural Anesthesia Kit
- Reason for recall
- The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- An URGENT MEDICAL DEVICE RECALL notification letter dated 5/21/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-082-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
- Quantity in commerce
- 1,512 kits
- Distribution
- US Nationwide distribution.
- Product codes and lots
- 1) PAIN0072L, UDI-DI: 10198459544163(each), 40198459544164(case), Lot Number: 25JDB100; 2) PAIN1317, UDI-DI: 10888277797109(each), 40888277797100(case), Lot Number: 25JLA788; 3) PAIN1579A, UDI-DI: 10193489422443(each), 40193489422444(case), Lot Number: 25JLA779; 4) PAIN1885A, UDI-DI: 10195327486310(each), 40195327486311(case), Lot Number: 25JLA861; 5) PAIN1967A, UDI-DI: 10198459241215(each), 40198459241216(case), Lot Number: 25JLA659; 6) PAIN2269, UDI-DI: 10198459342004(each), 40198459342005(case), Lot Number: 25JLA781; 7) PAIN2278, UDI-DI: 10198459376177(each), 40198459376178(case), Lot Number: 25JLA886; 8) PAIN2305, UDI-DI: 10198459478819(each), 40198459478810(case), Lot Number: 25JLA601; 9) PAIN2334, UDI-DI: 10198459540639(each), 40198459540630(case), Lot Number: 25JLA942; 10) SAMPA0147, UDI-DI: 10198459552809(each), 40198459552800(case), Lot Number: 25JLA928;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2533-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2534-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2535-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2536-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2537-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2538-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2539-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2540-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2541-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2542-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2543-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2544-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2545-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2546-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2547-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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