Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
Medical Action Industries, Inc. 306
Class I - Dangerous
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Siemens Healthcare Diagnostics
Class I - Dangerous
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Corin
Class I - Dangerous
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
E3800 PC Units (spare parts)
Radiometer Medical ApS
Class I - Dangerous
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Class I - Dangerous
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Class I - Dangerous
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.