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Terminated

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

FDA Recall Z-2096-2015 · Posted 2015-07-17

Recalling FirmCustom Healthcare Systems, Inc.
Recall StatusTerminated
Product CodeGCB
Date Initiated2014-11-05
Date Terminated2016-01-12
Product Quantity3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914

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.

Firm Action

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

Distribution Pattern

US Distribution to CT.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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