Device Recall Catheter Introducer

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

Cardiovascular Devices

2

No

US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain

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

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 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.