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Recall Observatory FDA recall evidence

Device product

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

Z-2096-2015

November 05, 2014

Class II

Product summary

Firm
Custom Healthcare Systems, Inc.
Event
Event 69762
Status
Terminated
Classification
Class II
Quantity
3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914
Official record key
device-enforcement:Z-2096-2015

Official wording

Reason: 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.

Code information: Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15

Distribution pattern: US Distribution to CT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.