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Sources: EU EUDAMED, US FDA
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Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system.
FDA Recall
Terminated
·SpineFrontier, Inc.·Product code FSM·April 22, 2013
Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.
FDA Recall
Terminated
·Integra York PA, Inc·Product code KCT·July 30, 2014
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code FSM·February 23, 2023
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
FDA Recall
Terminated
·Integra LifeSciences Corp·Product code LID·December 16, 2002
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code LID·December 14, 2001
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code GWO·August 6, 2015
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code GWO·August 6, 2015
Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450)
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code BTA·April 25, 2008
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 16, 2014
Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
FDA Recall
Open, Classified
·Nurse Assist, LLC·Product code FRO·November 6, 2023
Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade.
FDA Recall
Terminated
·Cygnus LLC·Product code JQC·September 8, 2005
Revogene, Catalog no. 610210. IVD test instrument
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code OOI·June 22, 2022
LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray is then sterilized. The primary sterile barrier is the inner sealed tray.
FDA Recall
Terminated
·Horizon Medical Products Inc·Product code LJT·September 20, 2004
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.
FDA Recall
Open, Classified
·Physio-Control, Inc.·Product code MKJ·January 14, 2021
Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Medium Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8749, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8750, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8751, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Medium 4 Latch, REF 50-8956, 445mm x 279mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Medium 4 Latch, REF 50-8957, 445mm x 279mm, QTY: 1,
FDA Recall
Terminated
·Symmetry Medical/SSI·Product code KCT·December 5, 2013
ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·May 8, 2002
Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the number of liners and lids purchased in one case without the individual boxes. The "H" denotes a single quantity when being ordered.
FDA Recall
Open, Classified
·Medline Industries Inc·Product code KDQ·January 31, 2019
Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.
FDA Recall
Terminated
·Bard Medical Division·Product code FMH·March 21, 2018
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JQP·May 15, 2007
Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.
FDA Recall
Terminated
·Kendall Healthcare Products Co·Product code LJS·April 27, 2005