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Crédits
Devices
Arrow
Modèle / numéro de série
Product No. AP-06040. Lot Numbers: MF2082014, MF2092092, MF2102287, MF2122972, MF3023424, MF3033561, MF3033608, MF3054587, MF3074949, MF3075147, MF3085288, MF3085340, MF3095656, MF3095740, MF3105983, MF3126394, MF4016539, MF4031048, MF4031211, MF4031352, MF4041932, MF4062931, MF4063056, MF4083962, MF4084405, MF4126532, MF5017410, MF5038601, MF5050044, MF5059734, MF5081723, MF5124399, MF6015389, MF6025738, MF6026066, MF6047369, MF6047370, MF6025851, MF6057763.
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. 9 Fr. Introducer Kit. || Ref Product No. AP -06040
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
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ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needles
Modèle / numéro de série
ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needlesProduct codes: BMHN1304VX, DBMNI1501, DBMNI1601, DBMNJ0804TL, DBMNJ1104TL, DBMNI1601Lot Numbers: 11095380, 11095842, 11098707, 11089370, 11096115, 11088295, 11094182, 11088597, 11090527ARTG Number: 223222
Manufacturer
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Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central v...
Modèle / numéro de série
Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous catheter)Catalogue number: PI-01451-LSBatch Numbers: 23F14J0437, 23F14K0406, 23F14B0935, 23F14H1535, 23F15A0278, 23F15D0907ARTG Number: 148783
Manufacturer
Teleflex Medical Australia Pty Ltd
Super Arrow-Flex Percutaneous Sheath Introducer Set
Modèle / numéro de série
Super Arrow-Flex Percutaneous Sheath Introducer SetSAP/Catalogue Numbers: CL-07635, CL-07735 and CL-07835Multiple batch numbers affectedARTG Number: 135922
Manufacturer
Teleflex Medical Australia Pty Ltd
ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits
Modèle / numéro de série
ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion KitsProduct Codes : IAB-05830-LWS, IAB-05830-U, IAB-05840-LWS, IAB-05840-U, IAB-06830-U, IAB-06840-U and IAK-06845Multiple Batch Numbers affectedARTG Numbers: 101617, 106866 and 107249
Classification du dispositif
Cardiovascular Devices
Manufacturer
Teleflex Medical Australia Pty Ltd
Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Su...
Modèle / numéro de série
Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits)Affected kits:BIOCUE STD KIT ACD-A W/BDProduct Number: 800-0613A GPS3 SINGLE KIT W/BLOOD DRAWProduct Number: 800-0675A GPS BONE BIOLOGICS KIT 20mL + S.TUBEProduct Number: TCP20GPSS.2MARROWSTIM CALCIBON KIT 20mLProduct Number: TCP20MARROWBIOCUE CALCIBON KIT 20mLProduct Number: TCP20BIOCUE ARTG #: 183209, 100053, 127024
Manufacturer
Zimmer Pty Ltd
565 en plus
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