Отзывы медицинских изделий FDA
Последние отзывы, исправления и изъятия медицинских изделий FDA. Следите за вопросами безопасности.
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 7…
Reusable access port system may crack or seperate during use.
Посмотреть отзыв FDA →Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULT…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wri…
Посмотреть отзыв FDA →Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 c…
Посмотреть отзыв FDA →Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22…
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-…
Посмотреть отзыв FDA →STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quan…
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Посмотреть отзыв FDA →Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal ox…
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 c…
Посмотреть отзыв FDA →Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Посмотреть отзыв FDA →MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
Посмотреть отзыв FDA →Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that deliver…
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resultin…
Посмотреть отзыв FDA →Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Посмотреть отзыв FDA →