Medline Kit Recall: Which ChloraPrep Products Are Affected?

✓ Primary sources checked | Published: | Evidence: FDA safety notice
FDA listed a Medline convenience-kit recall update on October 13. Certain kits contain recalled BD ChloraPrep applicators with potential fungal contamination. The notice reiterates existing product scope and actions; it is not a newly discovered October contamination event.
📅 Published:
✓ iMedic Editorial Team
📄 Treatment

Source announcement: . Published by iMedic on October 13, 2026.

Quick Facts

Authority
U.S. FDA
Product
Specified convenience kits
Action
Quarantine affected kits

Key takeaways

  • Check the full FDA product list and lot details.
  • For affected kits, follow the whole-kit disposal instructions.

Which components are involved?

Quick answer: The notice identifies two specific applicator lots.

They are ChloraPrep Clear 1 mL, item 930480, lot 4032183; and FREPP Clear 1.5 mL with paper lidding, item 930299, lot 4073005. Use the FDA notice and full kit list to check inventory.

What should affected facilities do?

Quick answer: Quarantine affected stock and follow the recall response process.

The instructions call for destroying the entire affected kit after completing response forms. Older stickers directing removal of one component do not replace the updated directions for these kits.

What does a serious recall classification mean?

Quick answer: It describes potential harm, not proof that every unit caused injury.

FDA explains that its most serious recall category reflects a reasonable chance of serious harm or death. Recall actions vary: some involve correction, others removal. Read the FDA explanation alongside the specific product notice.

Frequently Asked Questions

No. The action concerns the products identified in the notice.

No. The updated listing concerns an earlier recall.

No. The required action depends on the specific recall.

The manufacturer or another responsible company usually initiates it.

Ask the treating facility to compare its product records with the recall list.

References

  1. FDA: Medline convenience-kit removal notice. Checked October 13, 2026.
  2. FDA: October 13 CDRH news listing. Checked October 13, 2026.
  3. FDA: understanding medical device recalls. Checked October 13, 2026.

How was this news summary prepared?

iMedic Editorial Team checked this summary against the primary sources linked above. It reports a dated announcement and its limitations; it is not an individual treatment recommendation. Editorial standards.