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Sources: EU EUDAMED, US FDA
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Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of the humidified gas, to reduce condensation.
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BTT·October 22, 2008
V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.
FDA Recall
Terminated
·He, Inc·Product code GDI·March 1, 2010
Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
FDA Recall
Terminated
·Cardinal Health·Product code FTL·November 3, 2003
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code JHI·January 21, 2013
Recall of Alcohol Pads contained in the following kits distributed by Medtronic: ***REF 1529100***Thermasplint Kit, Small***X5***. ***REF 1529110***Thermasplint Kit, Medium***X5***. ***REF 1529120***Thermasplint Kit, Large***X5***. RECALLED PRODUCT - Front: ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. RECALLED PRODUCT - Back: ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.***
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code EPP·February 21, 2011
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code NVP·March 16, 2021
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code QBJ·March 16, 2021
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code JJW·April 20, 2020
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code LRO·November 16, 2018
Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code LZH·December 26, 2019
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code FMK·March 16, 2021
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code PQZ·April 20, 2020
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code LZH·December 26, 2019
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code NBW·March 16, 2021
GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of lesions in the auditory pathway on neonates through adults.
FDA Recall
Terminated
·Cardinal Health, Inc·Product code EWO·September 16, 2008
Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code LZH·December 26, 2019
VAPORIZER VICKS 1.5GAL Item Number: 2354942
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code KFZ·March 16, 2021
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code QLG·March 16, 2021
Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins.
FDA Recall
Terminated
·Cardinal Health, Inc·Product code IYN·January 6, 2009
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
FDA Recall
Open, Classified
·Cardinal Health Inc.·Product code LZH·December 26, 2019