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

FDA device recall Z-2096-2015 · posted 2015-07-17 · Terminated

Recall details

Recalling firm

Custom Healthcare Systems, Inc.

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.

Action taken

Custom Healthcare System sent an Urgent Product Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. PLEASE CHECK YOUR INVENTORY AND QUARANTINE ANY AFFECTED PRODUCT MATCHING THE DESCRIPTIONS ABOVE. Call 804 (421-5959) with regards to returning the affected products. Return Authorizations will be issued and product pickup and return will be scheduled.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

GCB

Quantity affected

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

Distribution

US Distribution to CT.

Date initiated

2014-11-05

Date posted

2015-07-17

Date terminated

2016-01-12

Location

Richmond, VA