Devices

Device Recall Catheter Introducer

Model / Serial
Lot Number: F2121485.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Product Description
Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries. Cook Inc., Bloomington, IN 47404
Manufacturer
Cook, Inc.
1 Event
- Recall of Device Recall Catheter Introducer

Manufacturer

Cook, Inc.

Manufacturer Address
Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
Source
USFDA

7 devices with a similar name

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Device Recall Catheter Introducer

Model / Serial
Lot Numbers: Q1176348 Q1178762 Q1194660 Q1206565 Q1201803 Q1209475 Q1213042 Q1228339 Q1234189X1 Q1234639 Q1182862 Q1190097 Q1194661 Q1197055 Q1202959 Q1213024 Q1215467 Q1234979 Q1174112 Q1197331 Q1176349 Q1213048 Q1182863 Q1228338 Q1194041 Q1206577 Q1214620 Q1184987 Q1194664 Q1213051 Q1237072 Q1213018 Q1205118 Q1175815 Q1194665 Q1197054 Q1193985 Q1193397 Q1209478 Q1228340 Q1176347 Q1204708 Q1182836 Q1170938 Q1161477 Q1185050 Q1234958 Q1176345 Q1193391 Q1228356 Q1175817 Q1194663 Q1215702 Q1228354 Q1201789
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain
Product Description
PreludeSNAP Splittable Hydrophilic and || non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
Manufacturer
Merit Medical Systems, Inc.

Device Recall Catheter introducer

Model / Serial
Catalog number MAP690; Lot numbers 01162 and 01186.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution including the states of FL, MA, WY. OH, MI and KS.
Product Description
MORPH ACCESSPRO Steerable Introducer; || 6F introducer, 90 cm working length: || Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: || BioCardia Inc. || San Carlos, CA 94070 || Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
Manufacturer
Biocardia, Inc.

Device Recall Catheter Introducer

Model / Serial
Catalog number MAP645 - Lot numbers: 1037 1048 1055 1059 1069 1073 1074 1079 1092 1095 1115 1118 1121 1125 1128 1130 1134 1147 1155 1164 1168 1169 1173 1177 1184 1190
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and country of: Israel.
Product Description
Morph AccessPro Steerable Introducer; || 6F Introducer, 45 cm working length || Single use only. || BioCardia, Inc. || San Carlos, CA 94070 || BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
Manufacturer
Biocardia, Inc.

Device Recall Catheter Introducer

Model / Serial
Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and country of: Israel.
Product Description
Morph AccessPro Steerable Introducer; || 6F Introducer, 90 cm working length: || Single use only. || BioCardia, Inc. || San Carlos, CA 94070 || BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
Manufacturer
Biocardia, Inc.

Device Recall CATHETER INTRODUCER KIT

Model / Serial
Catalog Number: 496185, Lot Number: 99738261, Expiration Date: 2014-07.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.
Product Description
CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx.. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
Manufacturer
Argon Medical Devices, Inc

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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