Safety PICC Insertion Tray with Chloraprep OneStep - - 12 pr case recalled over sterility concerns

Recall date

November 5, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Custom Healthcare Systems, Inc. recalls Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

Recall number

Z-2096-2015

FDA classification

Class II

Brand / firm

Custom Healthcare Systems, Inc.

Sold / distributed

US Distribution to CT.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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