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FAQ
Crédits
Devices
Arrow
Modèle / numéro de série
Product No. AP-06016. Lot Numbers: MF2092160, MF2092258, MF4031012, MF4041798, MF4063372, MF4073836, MF4105283, MF6015284, MF6026177.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Description du dispositif
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile Port. 6 Fr. Introducer Kit. || Ref. Product No. AP-06016.
Manufacturer
Arrow International Inc
1 Event
Rappel de Arrow
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Fabricant
Arrow International Inc
Adresse du fabricant
Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
Société-mère du fabricant (2017)
Teleflex Incorporated
Source
USFDA
570 dispositifs médicaux avec un nom similaire
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Arrow® HANDS-OFF® Thermodilution Catheter
Modèle / numéro de série
Product Codes: AH-05000, AH-05050, AH-05050-D Multiple Lot numbers of the affected device are provided in te attached FSN
Description du dispositif
Catheters
Manufacturer
Arrow International Inc.
ARROW® International PICC Kits with Peel-Away Sheath Component
Modèle / numéro de série
Products : ASK‐02041‐SEH1, CA‐05052‐HP, CDC‐34052‐VPS, EU‐05552‐HPMSB, ASK‐04001‐DU4, CA‐05052‐HPX, CDC‐35041‐VPS, FR‐04041, ASK‐04052‐AC, CDC‐02041‐MK1A, CDC‐35052‐VPS, FR‐04041‐CF, ASK‐05041‐LM4, CDC‐04041‐HPK1A, CDC‐35541‐VPS, FR‐05041, ASK‐05052‐SFL, CDC‐04052‐HPK1A, CDC‐35552‐VPS, FR‐05041‐CF, ASK‐05541‐MS2, CDC‐05041‐HPK1A, EU‐04041‐HP, FR‐05541‐CF, ASK‐05541‐MS3, CDC‐05052‐HPK1A, EU‐04041‐HPMSB, PI‐01451‐LS, ASK‐15552‐LM2, CDC‐05541‐HPK1A, EU‐04052‐HPMSB, PI‐01451‐LS5, ASK‐15552‐MS3, CDC‐05542‐PK1A, EU‐05041‐HPMSB, PK‐01451‐WS, ASK‐35041‐JHVA, CDC‐05552‐HPK1A, EU‐05052‐HPMSB, PK‐01451‐WSSP, CA‐05041‐HP, CDC‐15552‐HPK1A, EU‐05541‐HP, UK‐05041‐HPMIN, CA‐05041‐HPX, CDC‐34041‐VPS, EU‐05541‐HPMSB Lot Numbers: Refer to Appendix 2
Description du dispositif
catheter peel-away component
Manufacturer
Arrow International Inc
Narrow Right Angle Large Driver Tip (Hexed)
Modèle / numéro de série
Item: RASH3N Lot: 1184555 Item: RASQ3N Lot: 1184554
Description du dispositif
Driver Tip
Manufacturer
Biomet 3i Inc
Discovery MR450 narrow bore 1.5T MRI
Modèle / numéro de série
Discovery MR450, narrow bore 1.5T non-GEM. Distribution dates: June 2009 through July 2016.
Description du dispositif
MRI Coil
Manufacturer
GE Healthcare
ARROW OnControl Biopsy System Tray
Modèle / numéro de série
Product Codes: 9403‐EU‐006, 9403‐VC‐006, 9408‐EU‐006, 9408‐VC‐006, 9411‐EU‐006, 9411‐VC‐006, 9451‐VC‐006, 9458‐VC‐006, 9461‐VC‐001, 9461‐VC‐006, 9462‐EU‐001, 9462‐VC‐001, 9462‐VC‐006, 9463‐EU‐001, 9463‐VC‐001, 9463‐VC‐006, 9464‐EU‐001, 9464‐VC‐001, 9464‐VC‐006, 9465‐VC‐001, 9465‐VC‐006, 9466‐EU‐001, 9466‐VC‐001, 9466‐VC‐006, 9470‐VC‐006, 9471‐VC‐006, 9472‐VC‐006 Multiple lot numbers of the affected device are provided in the attached FSN.
Description du dispositif
Bone Marrow Biopsy System
Manufacturer
Teleflex Medical
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