FDA Device

Kit: Central Line Dres Change 20/Cs

Hazard

The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.

What You Should Do

Remedy

A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level.

Products

Kit: Central Line Dres Change 20/Cs
Brand
Medical Action Industries, Inc.
UPC
Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024  UDI: 20809160170523

Units Affected

42 cases