Custom Medical Specialties, Inc.

FDA Regulatory Profile

Summary

Total Recalls
21 (12 Class I)
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1234-2017Class IICMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, ManufactureSeptember 20, 2016
Z-0974-2014Class II5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine July 12, 2013
D-1649-2012Class IICustom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), July 23, 2012
D-1651-2012Class IICMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, ManufacJuly 23, 2012
D-1650-2012Class IICMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMSJuly 23, 2012
Z-2358-2012Class ICMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contaiSeptember 30, 2011
Z-2354-2012Class ICMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: UsagSeptember 30, 2011
Z-2357-2012Class ICMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep SSeptember 30, 2011
Z-2360-2012Class IBR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product USeptember 30, 2011
Z-2350-2012Class ICMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: September 30, 2011
Z-2356-2012Class ICMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: TheSeptember 30, 2011
Z-2355-2012Class ICMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack contaiSeptember 30, 2011
Z-2351-2012Class ICMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVSeptember 30, 2011
Z-2359-2012Class ICMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: TSeptember 30, 2011
Z-2352-2012Class ICMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: TheSeptember 30, 2011
Z-2328-2012Class IICMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in thSeptember 30, 2011
Z-2331-2012Class IICMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram TraySeptember 30, 2011
Z-2329-2012Class IICMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in September 30, 2011
Z-2330-2012Class IICMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kSeptember 30, 2011
Z-2353-2012Class ICMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PSeptember 30, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K944988CUSTOM MEDICAL SUSPENSION STRAPJanuary 27, 1995