FDA 醫療器材召回
FDA 最新醫療器材召回、修正與移除資訊。即時掌握影響醫療器材的安全問題。
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.
查看 FDA 召回 →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…
查看 FDA 召回 →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…
查看 FDA 召回 →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-…
查看 FDA 召回 →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
查看 FDA 召回 →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…
查看 FDA 召回 →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.
查看 FDA 召回 →MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
查看 FDA 召回 →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…
查看 FDA 召回 →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.
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