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Custom Medical Specialties Recalls
21 recalls on record · August 29, 2012 to March 1, 2017 · Drugs, Medical Devices
Recalls by year
12
14
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 1, 2017Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Med
Hazard: Sterility of syringe product could not be assured.
February 19, 2014Medical DevicesFDA
Custom Medical Specialties, Inc. recalls 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (
Hazard: No endotoxin (LAL) testing to proper level.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PV
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is us
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product U
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in th
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PV
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP containe
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in th
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the k
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained i
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
September 26, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is
Hazard: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
September 19, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bo
Hazard: The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
September 19, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin p
Hazard: The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
September 19, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Hazard: The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
September 19, 2012Medical DevicesFDA
Custom Medical Specialties, Inc. recalls CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in ski
Hazard: The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
August 29, 2012DrugsFDA
Custom Medical Specialties, Inc. recalls CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom
Hazard: Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
August 29, 2012DrugsFDA
Custom Medical Specialties, Inc. recalls CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Spe
Hazard: Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
August 29, 2012DrugsFDA
Custom Medical Specialties, Inc. recalls Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM
Hazard: Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags