586 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code CBK·October 1, 2014
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
FDA Enforcement
Class I
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·December 17, 2014
BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code GXY·November 8, 2011
LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Road, Shanghai 201114, P.R. Chin., Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·November 4, 2011
LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleylab a division of Tyco Healthcare Group LP, Boulder, CO 80301, Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Rd., Shanghai 201114, P.R. China. Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·November 4, 2011
Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin
FDA Recall
Terminated
·Covidien LLC·Product code FMF·May 21, 2012
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
FDA Recall
Terminated
·Covidien LLC·Product code NGT·August 16, 2013
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
FDA Recall
Terminated
·Covidien LLC·Product code DRO·April 8, 2013
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
FDA Recall
Terminated
·Covidien LLC·Product code MSD·April 23, 2015
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
FDA Recall
Terminated
·Covidien LLC·Product code MSD·April 23, 2015
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Recall
Terminated
·Covidien LLC·Product code EZL·January 22, 2016
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
FDA Recall
Terminated
·Covidien LLC·Product code DRO·August 19, 2015
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
FDA Recall
Terminated
·Covidien LLC·Product code NGT·August 6, 2015
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
FDA Recall
Terminated
·Covidien LLC·Product code NGT·August 6, 2015
Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
FDA Recall
Terminated
·Covidien LLC·Product code FFT·April 15, 2016