Отзывы медицинских изделий FDA
Последние отзывы, исправления и изъятия медицинских изделий FDA. Следите за вопросами безопасности.
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and…
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of t…
Посмотреть отзыв FDA →Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressur…
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Посмотреть отзыв FDA →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing proc…
Посмотреть отзыв FDA →Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstr…
Посмотреть отзыв FDA →Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod…
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected t…
Посмотреть отзыв FDA →INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. …
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss o…
Посмотреть отзыв FDA →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN …
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing proc…
Посмотреть отзыв FDA →5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may …
Посмотреть отзыв FDA →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBO…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing proc…
Посмотреть отзыв FDA →Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: …
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, all…
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