FDA-Device2026-07-08Class IIPROCESSING DEFECT

Medline epidural and pain management kits recalled for lidocaine quality issues

OTHERNationwide distributionMedical devices

What this means

Medline distributed convenience kits containing lidocaine ampules manufactured by Huons Co., Ltd. The FDA identified quality issues with the lidocaine during a manufacturing inspection of Huons' facility. The affected kits are used for epidural anesthesia and pain management procedures.

Check if your facility has any of the affected Medline kit model numbers (PAIN0072L, PAIN1317, PAIN1579A, PAIN1885A, PAIN1967A, PAIN2269, PAIN2278, PAIN2305, PAIN2334, or SAMPA0147).
Do not use kits with lot numbers 25JDB100, 25JLA788, 25JLA779, 25JLA861, 25JLA659, 25JLA781, 25JLA886, 25JLA601, 25JLA942, or 25JLA928.
Contact Medline for guidance on replacement kits or return instructions.

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

US Nationwide distribution.

Affected count

1,512 kits

Manufactured in

3 Lakes Dr, N/A, Northfield, IL, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2534-2026

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