Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp,
FDA device recall Z-0968-2011 · posted 2011-01-26 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterlized but the product actually was sterilzed with gamma radiation.
- Action taken
- Terumo Cardiovascular Systems Corporation firm sent out an 'URGENT MEDICAL DEVICE CORRECTION: SAFETY ADVISORY" letter dated October 20, 2010, to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Safety Advisory, assure that all users were aware of the notice, and confirm receipt of the Safety Advisory by faxing the attached Customer Response Form to the fax number on the form. For questions regarding this recall call 1-800-521-2818.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- GFA
- Quantity affected
- 42,650 units, 4265 boxes of 10 each
- Distribution
- US, Indonesia, UAE, Hong Kong, Japan, Singapore, Malaysia, Taiwan, Belgium, Uraguay, Venezuela, Columbia, Mexico, Guam, Vietnam and Thailand.
- Date initiated
- 2010-10-20
- Date posted
- 2011-01-26
- Date terminated
- 2011-12-14
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK (K935391) | 3M Health Care, Sarns | 1994-02-24 |