| Class 2 Device Recall Celsius Thermocool products and Navistar Thermocool products | |
Date Initiated by Firm | August 08, 2005 |
Date Posted | October 15, 2005 |
Recall Status1 |
Terminated 3 on May 23, 2008 |
Recall Number | Z-0057-06 |
Recall Event ID |
32925 |
PMA Number | P030031 |
Product Classification |
Cardiac Ablation Percutaneous Catheter - Product Code LPB
|
Product | Thermocool Irrigated Catheters
Celsius
LABEL US Part Number# EU CATALOG #
L-1189-01-S D17TCBLRT 35Q-13R PMA;
L-1189-02-S D17TCDLRT 35Q-33R PMA;
L-1189-03-S D17TCFLRT 35Q-53R PMA;
L-1189-04-S D17TCJLRT 35Q-73R PMA;
L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT;
L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT;
L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT;
L-1189-03-S D71TFL252RT 35R-53R EXPORT;
L-1192-03-S D71TFL252RT 35R-53R EXPORT;
L-1192-15-S D71TB5L252RT 35R-17R EXPORT;
L-1192-16-S D7ITD5L252RT 35R-37R EXPORT;
L-1189-02-SI D17TCDLRTI N/A IDE;
L-1189-15-SI D71TCB5L252RTI N/A IDE;
L-1189-16-SI D71TCD5L252RTI N/A IDE;
L-1189-17-SI D71CF5L252RTI N/A IDE
Navistar
LABEL US Part Number# EU CATALOG #
L-1192-17-S D71TF5L252RT 35R-57R EXPORT;
L-1197-14-S NI75TCBH 34H-17M PMA;
L-1197-15-S NI75TCCH 34H-27M PMA;
L-1197-16-S NI75TCDH 34H-37M PMA;
L-1197-17-S NI75TCFH 34H-57M PMA;
L-1197-18-S NI75TCJH 34H-J7M PMA;
L-1208-05-S NS75TBCT252HS 34G-17M PMA;
L-1208-06-S NS75TCCT252HS 34G-27M PMA;
L-1208-07-S NS75TDCT252HS 34G-37M PMA;
L-1208-08-S NS75TFCT252HS 34G-57M PMA;
L-1197-14-SI NI75TCBHI N/A IDE;
L-1197-15-SI NI75TCCHI N/A IDE;
L-1197-16-SI NI75TCDHI N/A IDE;
L-1197-17-SI NI75TCFHI N/A IDE;
L-1197-18-SI NI75TCJHI N/A IDE;
L-1208-05-SI NS75TBCT252HSI N/A IDE;
L-1208-06-SI NS75TCCT252HSI N/A IDE;
L-1208-07-SI NS75TDCT252HSI N/A IDE;
L-1208-08-SI NS75TFCT252HSI N/A IDE |
Code Information |
Lots 13027030 to 13044734 |
Recalling Firm/ Manufacturer |
Biosense Webster, Inc. 15715 Arrow Hwy Irwindale CA 91706-2006
|
For Additional Information Contact | Mary McDermott 909-839-8720 |
Manufacturer Reason for Recall | Increased complaints regarding catheters with leaks and flow obstruction. |
FDA Determined Cause 2 | Other |
Action | Urgent letters and response forms dated August 8, 2005 directed consignees to return product. |
Quantity in Commerce | 9,679 |
Distribution | FL, iL, MA, MI, OH, OK and Belguin, Netherlands, Australia, Japan, Korea, India, Sri Lanka, New Zealand,
China, Hong Kong, Singapore, Pakistan, Canada |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database | PMAs with Product Code = LPB
|
|
|
|