FDA-Device2015-07-29Class II
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Custom Healthcare Systems, Inc.
Hazard
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.
Sold states
US Distribution to CT.
Affected count
3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914
Manufactured in
4205 Eubank Rd, N/A, Richmond, VA, United States
Products
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2096-2015Don't want to check this manually?
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