Custom Healthcare Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2096-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 5, 2014

Date Posted: July 29, 2015

Recall Number: Z-2096-2015

Event ID: 69762

Reason for Recall:

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.

Status: Terminated

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

Code Information:

Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15

Distribution Pattern:

US Distribution to CT.

Voluntary or Mandated:

Voluntary: Firm initiated