Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.
This recall has been terminated (originally issued September 25, 2012).
- Recall Initiated
- August 9, 2012
- Posted
- September 25, 2012
- Terminated
- March 22, 2013
- Recall Number
- Z-2448-2012
- Quantity
- 40,238 units for all products in Recall Event
- Firm Location
- Margarita, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
Lot / Code Info
Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.
Root Cause
Material/Component Contamination
Action Taken
Applied Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to complete the attached Recall Notification Confirmation Form and to return it to the firm via e-mail to recall60476587@appliedmedical.com or fax to (949) 713-8832. For product return questions, customers were instructed to contact Sales Operations Administrator at (949) 713-8652.For questions regarding this recall contact the firm at (949) 713-8041.