65 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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Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp, femoral angiography drape,needle 18G,& Guidewire EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014
NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code OEQ·January 9, 2015
ANGIOGRAPHY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·July 10, 2015
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code OEQ·January 9, 2015
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code OEQ·January 9, 2015
Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·January 7, 2016
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
FDA Recall
Terminated
·Medline Industries Inc·Product code OEQ·September 14, 2020
ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014
Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·October 8, 2014
Angiography Pack, Catalog number 900-610. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·October 8, 2014
NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code OEQ·January 9, 2015
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code OEQ·January 9, 2015
FEMORAL ANGIOGRAPHY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·July 10, 2015
ANGIOGRAPHY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·July 10, 2015
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OEQ·July 9, 2018
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
FDA Recall
Terminated
·Medline Industries Inc·Product code OEQ·September 14, 2020
ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·July 10, 2015
Angiography Pack, Catalog number 900-2038. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·October 8, 2014
NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code OEQ·January 9, 2015
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OEQ·November 10, 2020