Reported Jul 29, 2015 · Terminated
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Custom Healthcare Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Custom Healthcare Systems, Inc. · 4205 Eubank Rd · Richmond, VA · 23231-4328
Is this the product you have?
- Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
- Lot codes and dates
- Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15
- Amount recalled
- 3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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