Tecnología Médica

Tecnología Médica

Hemashield Gold Knitted Graft
02/02/2023 - Product was identified as potentially non-sterile as it received an underdose of gamma irradiation during the sterilization process. As the sterilization dose was not achieved, the sterility...
Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect
31/01/2023 - A catheter hub defect may cause the Mahurkar Acute Dual Lumen High Flow Catheter to leak across the catheter’s two tubes.
Nasal Septal Button, 5-Cm
27/01/2023 - Summit Medical received a customer complaint that Nasal Septal Button, 5cm, SP-78105 parts received from lot# 219349 were in unsealed pouched. The product was sterilized, but if this sterile barrier...
Hickman And Leonard Lumen CV Catheters
26/01/2023 - The catheter repair adhesive used to attach the repair segment to the original catheter is hardened/coagulated (unusable). Recall start date: January 4, 2023
Nuzone X2 Synthetic Polychloroprene Sterile Surgical Gloves Powder Free
26/01/2023 - The recall is due to quality complaints from health care professionals that the gloves may not meet their intended use in a medical/surgical setting. The gloves easily tear and may result in...
Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm
26/01/2023 - Blood may enter the Cardiosave IABP through a damaged balloon catheter, causing pump shut-down, or patient exposure to helium or cross-contaminated blood
Medline Custom Procedure Packs - Non-absorbable sutures
25/01/2023 - Medline Industries, LP is recalling custom procedure packs containing medtronic non-absorbable sutures due to a manufacturing error in the packaging of the sutures that may cause a gap or wrinkle...
Cannula, Neonate, Oxygen W/3-Channel Tube 7' - 50/Cs
25/01/2023 - These pediatric nasal oxygen cannulas had sticky film when package was opened -  expired product or nearly expired product released placticizer film. Recall start date: December 05, 2022
Prehma Disposable Dental Needles
24/01/2023 - Importation and sale of an unlicensed class II medical device. Recall start date: December 20, 2022
Teleflex Stylet, Endotracheal Kit and Flexi-Set
26/12/2022 - Teleflex has initiated a voluntary field safety corrective action due to reports of pilot balloon non-inflation or cuff non-deflation. In the event of pilot balloon non-inflation, there is a...
Medline Packs
16/12/2022 - Medline packs contain 3M's Steri-drape, which are recalled due to the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the...
Med-Rx Universal Anesthesia Kits
15/12/2022 - This recall addresses a product concern regarding the drapes in the kit. The supplier (3M) decided to recall the drapes in the kit because it was confirmed that the liner on the adhesive component of...
Medtronic Nonabsorbable Sutures
14/12/2022 - Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile...
PDS (Polydioxanone) Monofilament Suture
02/12/2022 - Returned representative unopened samples were evaluated for knot tensile strength and a portion of samples were observed to be significantly below the minimum knot tensile force requirement. Low...
Single Use Oats Set
22/11/2022 - Complaint reports indicate there is a possibility the 8mm reamer in AR-8981-08s may measure 6mm, and the 6mm reamer in AR-8981-06s may measure 8mm.  Recall start date: November 2, 2022
Safety Cartridge Sterile
16/11/2022 - Lot w92761 was not sent for sterilization but it was released for sale as non-sterile product labelled as sterile. Recall start date: October 28, 2022
Cese de utilización del lote 2I103 de la sonda intermitente hidrofílica Onli Ch12 40cm
14/11/2022 - La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través del fabricante Hollister Incorporated, Estados Unidos, del cese de...
Disposición N° 8067/2022
10/11/2022 - Prohíbese el uso, la comercialización y la distribución en todo el territorio nacional de todos los lotes y medidas de los productos rotulados como AZDENT ORTHODONTIC BUCCAL...
Disposición N° 8070/2022
10/11/2022 - Prohíbese el uso, comercialización y distribución en todo el territorio nacional de los productos rotulados como: 1) KIT ESTERIL PARA IMPLANTES – BIOPREX indumentaria...
Disposición N° 8075/2022
10/11/2022 - Prohíbese el uso, comercialización y distribución en todo el territorio nacional de los productos rotulados como: “SILK BRAIDED – Non Absorbable Suture –...
Neo-Fit Neonatal Endotracheal Tube Grip
10/11/2022 - Coopersurgical has become aware of a potential health risk in which metal clips used to grip the neonatal endotracheal tube may fracture and detach from the strap and then be ingested by the...