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Custom Healthcare Systems Recalls
33 recalls on record · February 13, 2013 to February 5, 2020 · Medical Devices
Recalls by year
13
15
18
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2015Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
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.
February 13, 2013Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Produ
Hazard: Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
February 13, 2013Medical DevicesFDA
Custom Healthcare Systems, Inc. recalls Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile
Hazard: Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.