47 results · 10ms · Sources: EU EUDAMED, US FDA

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Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.

FDA Enforcement
Class II ·Terminated·J T Posey Company·April 17, 2013

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3342-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.

FDA Recall
Terminated ·Cardinal Health·Product code CBT·June 27, 2016

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3372-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A Needle w/Eclipse, 25U Balanced Heparin, No CE, part number: 3373-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.

FDA Recall
Terminated ·Medspira, Llc·Product code GBT·June 14, 2017

Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care. Product Usage: Humidifier - single patient use. used with supplemental oxygen therapy.

FDA Recall
Terminated ·SALTER LABS·Product code BBT·October 21, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016

FDA Recall
Terminated ·Smiths Medical Asd Inc·Product code CBT·November 21, 2007

AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.

FDA Recall
Terminated ·Vyaire Medical·Product code CBT·July 18, 2017

Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medical ASD, Inc, Dublin, Ohio 43016

FDA Recall
Terminated ·Smiths Medical Asd Inc·Product code CBT·November 21, 2007

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011

Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95S. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

FDA Recall
Terminated ·Westmed Inc·Product code CBT·January 18, 2011