Recall Weekly
Moderate riskFDA DeviceClass II

Medline pediatric and cardiac surgical kits recalled for potential Bacillus contamination

Medline Industries is recalling specific pediatric open heart and cardiac surgical convenience kits that contain BD PurPrep solution potentially contaminated with low levels of Bacillus species. The affected kits were distributed to healthcare facilities in 10 states. No injuries have been reported.

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

What to do

  1. Check your facility's inventory for the affected Medline kit SKUs (DYNJ910103B or DYNJ910961A) and lot numbers listed in this recall
  2. Do not use kits with lot numbers 25FBR237, 25ABM761, 25BBD107, 25FBD534, or 25FBL772
  3. Contact Medline Industries or your distributor for instructions on return or replacement
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
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
155 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-2788-2026

In the FDA's words

Description
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A. 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 DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772. Distribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA. Affected quantity: 155 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.

More from Medline

See all

Related topics

BacillusSterilityMedical devicesCTFLKSMAMDMTNYOHORVAMore from FDA Device