Incomplete seals on the sterile package may compromise the sterility
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
Pacific Medical Group
Class I - Dangerous
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Pacific Medical Group
Class I - Dangerous
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ.
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.
Class I - Dangerous
Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label
Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
Centurion Medical Products
Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Incomplete seals on the sterile package may compromise the sterility
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Class I - Dangerous
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
Cardinal Health
Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.