Class I - Dangerous
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
🏨
Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Class I - Dangerous
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Class I - Dangerous
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinations.
Medical Positioning
Class I - Dangerous
Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.
Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.
Medical Positioning
Class I - Dangerous
Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.
Class I - Dangerous
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.
Medical Positioning
Class I - Dangerous
Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.
Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Class I - Dangerous
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Class I - Dangerous
The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.
Class I - Dangerous
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Class I - Dangerous
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Class I - Dangerous
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
BD Biosciences, Systems & Reagents
Class I - Dangerous
The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02
Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Class I - Dangerous
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Class I - Dangerous
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Carestream Health
Class I - Dangerous
The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Carestream Health
Class I - Dangerous
The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
PerkinElmer Health Sciences
Class I - Dangerous
Potential for demographic information and test result to be mismatch.
Latex Dental Dams labeled as Non-Latex Dental Dams
Coltene Whaledent
Class I - Dangerous
Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.
IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
Wellspring Pharmaceutical
Class I - Dangerous
Potential for microbial contamination of the product.