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U.S. Department of Health and Human Services

Class 2 Device Recall Safety PICC Insertion Tray with Chloraprep OneStep

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 Class 2 Device Recall Safety PICC Insertion Tray with Chloraprep OneStepsee related information
Date Initiated by FirmNovember 05, 2014
Date PostedJuly 17, 2015
Recall Status1 Terminated 3 on January 12, 2016
Recall NumberZ-2096-2015
Recall Event ID 69762
Product Classification Needle, catheter - Product Code GCB
ProductSafety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Code Information Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15 
Recalling Firm/
Manufacturer		 Custom Healthcare Systems, Inc.
4205 Eubank Rd
Richmond VA 23231-4328
For Additional Information ContactCarol Heath
804-421-5959
Manufacturer 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.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionCustom 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.
Quantity in Commerce3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914
DistributionUS Distribution to CT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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