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Sources: EU EUDAMED, US FDA
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MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
FDA Recall
Terminated
·Oridion Medical·Product code CCK·March 25, 2011
MicroStream Filterline Infant/Neonatal products: Part # 008598 - FILTERLINE H SET INF/NEO 25UN DRAEGER(Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
FDA Recall
Terminated
·Oridion Medical·Product code CCK·March 25, 2011
MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
FDA Recall
Terminated
·Oridion Medical·Product code CCK·March 25, 2011
Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
FDA Recall
Terminated
·Oridion Medical·Product code CCK·March 25, 2011
Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex-2 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540930001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex-1 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540824001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex-2 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540956001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex-1 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540905001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Accu-Chek Ultraflex-2 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540948001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/ 1/8" Drain Spec., 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2550-702-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/ 1/4" Drain Spec, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2550-704-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/ 3/32" Drain, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2550-001-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008