Moderate riskFDA DeviceClass II

Medline NEURO PACK medical kits recalled for Bacillus contamination

Medline Industries recalled specific NEURO PACK medical convenience kits because the included BD PurPrep 26 mL solution may contain low levels of Bacillus species bacteria. The contamination was identified in kits distributed to hospitals and medical facilities in 10 U.S. states.

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

What to do

  1. Check your NEURO PACK kits for lot numbers 25AMJ225, 25CMF838, 24KME164, 25DMB248, 25FMD941, 25GMB662, or 25GMG296.
  2. Stop using affected kits immediately.
  3. Contact Medline Industries or your supplier for return instructions and replacement kits.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P
Sold in
US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Made for
All ages (under 100 years)

This recall covers 4 products — see all of them.

Details

Units affected
574 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-2790-2026

In the FDA's words

Description
Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. UDI/DI 10198459098109 (each) 40198459098100 (case), Lot Numbers: 25AMJ225, 25CMF838, 24KME164, 25DMB248, 25FMD941, 25GMB662, 25GMG296. Distribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA. Affected quantity: 574 kits
Hazard
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

4 products in this recall

Medline convenience kits with BD PurPrep recalled for Bacillus risk

Medline is recalling specific medical convenience kits that include BD PurPrep 26 mL antiseptic skin prep. The prep may contain low levels of Bacillus bacteria. The recall covers four product listings, and no injuries have been reported.

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

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