Device Recall Catheter Introducer

Catalog number MAP690; Lot numbers 01162 and 01186.

Cardiovascular Devices

2

No

US Distribution including the states of FL, MA, WY. OH, MI and KS.

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.

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

Cardiovascular Devices

2

No

Worldwide Distribution: US (nationwide) and country of: Israel.

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.

Catalog number MAP690 -lot numbers:  1051  1063  1083  1106  1119  1137  1138  1140  1146  1148  1151  1154  1160  1162  1183  1186

Cardiovascular Devices

2

No

Worldwide Distribution: US (nationwide) and country of: Israel.

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.

Lot Number: F2121485.

Cardiovascular Devices

2

No

Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.

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

Catalog Number: 496185, Lot Number: 99738261, Expiration Date: 2014-07.

Cardiovascular Devices

2

No

Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.

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.