| |
Medical Device Recalls
Class 2 Recall
St Jude Medica CPS Direct SL
|
|
Date Recall
Initiated |
March 20, 2007
|
| Date Posted |
June 14, 2007
|
| Recall Number |
Z-0933-2007
|
| Product |
St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.
|
| Code Information |
Models: CPS Direct SL (Models 410110; 410111; 410112; 410113; 410114; 410115; 410116; 410120; 410121; 410122; 410123; 410124; 410126).
CODE INFORMATION: All devices with sterile lot numbers beginning with S, CR, or any C4 lot numbers starting with CP 05274 or higher.
|
Recalling Firm/
Manufacturer |
St Jude Medical CRMD
15900 Valley View Ct
Sylmar
, California
91342-3577
|
| For Addition Information Contact |
Nestor Kusnierz
818-493-2587
|
Reason For
Recall |
Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.
|
| Action |
By Letter dated March 20, 2007, customers were requested to returned affected product immediately to St. Jude Medical. St. Judes Sales Representative will be assisting customers in retrieving the subject inventory from their shelves.
The firm instructed customers that if they should require further information regarding this issue, to contact the firm's Technical Service department at (800) 722-3774 or customers can contact local St. Jude Medical representative.
|
| Quantity in Commerce |
14,000
|
| Distribution |
Worldwide-including states of AZ, CA DC, FL GA, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NH, NY, OH, PA, RI, TN, VA, and WI and countries of Austria, Belgium, Denmark, Finland, Netherlands, Sweden, France, Germany, Italy, UK, Spain, Portugal, Poland, Switzerland, Australia, New Zealand, Thailand, Hong Kong, Korea, Malaysia and Singapore.
|
| |
|
|
|
|
