6 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2505-000-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2505-700-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 14, 2017
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 14, 2017
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTS·September 29, 2004
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013