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Showing 23261–23280 of 29086 results

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UniFuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 1... (Angiodynamics, Inc.) – angiodynamics became aware that unif... (2014)

AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

Class IIModerate

FDAAug 6, 2014Nationwide• Angiodynamics, Inc.

Alcohol-Free Hand Sanitizer (Humphreyline) – Microbial Contamination (2014)

Microbial Contamination of Non-Sterile Product

Class IIModerate

FDAAug 6, 2014KY, MD, VA• HLI dba Humphreyline Inc

Port Access Kit with MicroClave Clear Connector, Item No.... (ICU Medical, Inc.) – icu medical is recalling the bd posif... (2014)

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.

Cap Change Kit with MicroClave Clear Connector, Item No. ... (ICU Medical, Inc.) – icu medical is recalling the bd posif... (2014)

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.

CAP Change Kit w/MicroClave Clear, Item No. B78109 BD ... (ICU Medical, Inc.) – icu medical is recalling the bd posif... (2014)

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.

CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and C... (Curbell Medical, Inc.) – the firm became aware of a potential ... (2014)

The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.

Class IIModerate

FDAAug 5, 2014Nationwide• Curbell Medical, Inc.

DualCap IV Pole Strips Disinfectant Caps for Luer Access ... (Catheter Connections, Inc.) – catheter connections is recalling dua... (2014)

Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.

Class IIModerate

FDAAug 5, 2014CT, GA, MD +1 more• Catheter Connections, Inc.

Atenolol Tablets (Zydus) – Superpotent Drug Concern (2014)

Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.

Class IIModerate

FDAAug 5, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Wheat Cake (Ikko Trading) – Undeclared Ingredient (2014)

This voluntary recall has been initiated because Maruto 'C' Cakes (Wheat Cakes) omitted soy lecithin as an ingredient and an accompanying allergen warning.

Class IIModerate

FDAAug 5, 2014IL• Ikko International Trading LLC

RegeneSlim Appetite Control (Regeneca) – DMAA Contamination (2014)

RegeneSlim was found to contain DMAA by FDA analysis.

Class IIModerate

FDAAug 4, 2014Nationwide• Regeneca, Inc

Split Cath III Trays, 16F x 28CM Product Usage: The... (Medical Components, Inc dba MedComp) – the split cath iii trays were incorre... (2014)

The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.

Class IIModerate

FDAAug 4, 2014Nationwide• Medical Components, Inc dba MedComp

ProSol Amino Acid Injection (Baxter) – Particulate Contamination (2014)

Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).

Class IIModerate

FDAAug 4, 2014Nationwide• Baxter Healthcare Corp

Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/... (EMG Technology Co., Ltd.) – suction canister lids may have occlud... (2014)

suction canister lids may have occluded ports.

Class IIModerate

FDAAug 3, 2014IL, IN• EMG Technology Co., Ltd.

ST¿CKERT HeaterCooler System 3T; Item Number 160281, H... (Sorin Group USA, Inc.) – on august 1, 2014 sorin group usa, inc (2014)

On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).

Class IIModerate

FDAAug 1, 2014Nationwide• Sorin Group USA, Inc.

CollectEVAC, Sterile device with tubing and adaptor for u... (Civco Medical Instruments Inc) – a pinhole leak identified in the pack... (2014)

A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.

Class IIModerate

FDAAug 1, 2014AZ, IL, LA +13 more• Civco Medical Instruments Inc

CYTARAbine for Injection (Ben Venue) – sterility concerns (2014)

Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.

Class IIModerate

FDAJul 31, 2014Nationwide• Ben Venue Laboratories Inc

Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: (Mindray DS USA, Inc. dba Mindray North America) – mindray ds usa inc (2014)

Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.

Class IIModerate

FDAJul 31, 2014Nationwide• Mindray DS USA, Inc. dba Mindray North America

Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model ... (Philips Electronics North America Corporation) – philips, pinnacle radiation treatment... (2014)

Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.

Class IIModerate

FDAJul 31, 2014Nationwide• Philips Electronics North America Corporation

Philips Brilliance iCT Computed Tomography X-Ray System ... (Philips Medical Systems, Inc.) – it was discovered that a software de... (2014)

It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

Class IIModerate

FDAJul 31, 2014Nationwide• Philips Medical Systems, Inc.

CareFusion AirLife Heated Infant Breathing Circuit Pro... (Carefusion 2200 Inc) – the carefusion airlife heated infant ... (2014)

The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.

Class IIModerate

FDAJul 31, 2014Nationwide• Carefusion 2200 Inc

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