Recall Weekly
Moderate riskFDA DeviceClass II

Medline medical convenience kits recalled for potential Bacillus contamination

Medline Industries is recalling three types of medical convenience kits (Shoulder Pack and Major Ortho Kit models) because the BD PurPrep solution included in them may contain low levels of Bacillus species bacteria. The contamination was discovered in specific lot numbers distributed across ten U.S. states.

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

What to do

  1. Check if you have one of the affected kits (SKU DYNJ39590O, DYNJ88566, or DYNJ911535) and verify the lot number on the package.
  2. Do not use the BD PurPrep 26 mL solution from the recalled kits.
  3. Contact Medline Industries or your medical supplier for instructions on returning or replacing the affected kits.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.
Sold in
US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
398 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-2789-2026

In the FDA's words

Description
Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535. 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. Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 24LBF187; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25ABM992; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25CBJ129; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25DBI743; Medline Kit SKU DYNJ88566, UDI/DI 10198459179235 (each) 40198459179236 (case), Lot Number 24KBK487; Medline Kit SKU DYNJ911535, UDI/DI 10198459377600 (each) 40198459377601 (case), Lot Number 25FBU802. Distribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA. Affected quantity: 398 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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