Recall Z-2096-2015— Custom Healthcare Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Custom Healthcare Systems, Inc., initiated 2014-11-05, terminated 2016-01-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.. 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..
- Recalling firm
- Custom Healthcare Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-05
- Terminated
- 2016-01-12
- Firm location
- Richmond, VA, United States
Product description
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.