Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 Recalled by Custom Healthcare Systems, Inc. Due to An INCORRECT item number is packed within the...

Date: November 5, 2014
Company: Custom Healthcare Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Custom Healthcare Systems, Inc. directly.

Affected Products

Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

Quantity: 3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914

Why Was This Recalled?

An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The NON-STERILE OUTSIDE "PIGGYBACKED" PACKAGE mistakenly contains ITEM #8881579121 - Syringe prefilled, Saline Flush, 09% Sodium Chloride and is a NONSTERILE PRODUCT that CANNOT BE DROPPED INTO THE STERILE FIELD.

Where Was This Sold?

This product was distributed to 1 state: CT

Affected (1 state)Not affected

About Custom Healthcare Systems, Inc.

Custom Healthcare Systems, Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report