RecallDepth

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

Company
Biosense Webster, Inc.
Recall Initiated
August 8, 2005
Posted
October 15, 2005
Terminated
May 23, 2008
Recall Number
Z-0057-06
Quantity
9,679
Firm Location
Irwindale, CA

Reason for Recall

Increased complaints regarding catheters with leaks and flow obstruction.

Distribution

FL, iL, MA, MI, OH, OK and Belguin, Netherlands, Australia, Japan, Korea, India, Sri Lanka, New Zealand, China, Hong Kong, Singapore, Pakistan, Canada

Lot / Code Info

Lots 13027030 to 13044734

Root Cause

Other

Action Taken

Urgent letters and response forms dated August 8, 2005 directed consignees to return product.

More recalls by Biosense Webster, Inc.

View all recalls by this company →