Strauss Penis Clamp 130MM/General Instruments
Aesculap Implant Systems
Class I - Dangerous
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
🔪
Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
Teleflex Medical Europe
Class I - Dangerous
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Arrow International
Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Doyen-Collin Mouth Gag 120MM/ General Instruments
Aesculap Implant Systems
Class I - Dangerous
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
Arrow International
Class I - Dangerous
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
The infusion sets were manufactured with an incorrect spin collar.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
The infusion sets were manufactured with an incorrect spin collar.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
The infusion sets were manufactured with an incorrect spin collar.
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Ethicon
Class I - Dangerous
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Radial Artery Catheterization Kit; Model: AK-04220
Arrow International
Class I - Dangerous
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Radial Artery Catheterization Kit; Model: AK-04020
Arrow International
Class I - Dangerous
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Class I - Dangerous
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.