Serious riskFDA DeviceClass I

Medline HIP CDS-LF kits recalled for possible drug ineffectiveness

Medline medical procedure convenience kits (model HIP CDS-LF) contain pain management medications with quality issues that could make the medication ineffective. The affected kits were distributed in Missouri, Colorado, and Illinois. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if you have a Medline HIP CDS-LF kit with one of these lot numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, or 25GDA213.
  2. Do not use the kit if you have one of the affected lots.
  3. Contact Medline Industries for instructions on return or replacement.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Sold in
US: Mo, CO, IL
Made for
All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected
52 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class I
Recall number
Z-2764-2026

In the FDA's words

Description
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness. UDI/DI 10198459266621 (each) 40198459266622 (case), Lot Numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, 25GDA213. Distribution: US: Mo, CO, IL Affected quantity: 52 kits
Hazard
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

2 products in this recall

Medline procedure kits recalled for bupivacaine ineffectiveness risk

Medline is recalling 370 medical procedure convenience kits across two product entries. The kits include pain management kits made by ICU Medical that contain bupivacaine hydrochloride in dextrose injection, which was recalled over quality issues that could make the drug less effective. No injuries have been reported, and the kits were distributed in Missouri, Colorado, and Illinois.

The agency lists each product separately. Check every one you might have.

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