Recall Z-0515-2010
Merit Medical Systems, Inc. · initiated September 29, 2009
Product
Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with filtered Sosa spike. Used to transfer contrast or saline into a sterile injector syringe
Codes / lots: Lot #: D918208
Reason for recall
Potential sterility breach caused by excessive shipment damage.
FDA-determined cause: Other
Action taken
Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
Details
- Recall number
- Z-0515-2010
- Initiated
- September 29, 2009
- Posted by FDA
- December 14, 2009
- Terminated
- December 15, 2009
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 53 CT Transfer Sets
- Distribution
- US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0510-2010 | Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12"…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0511-2010 | Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0512-2010 | Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0513-2010 | Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0514-2010 | Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0516-2010 | Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0517-2010 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0518-2010 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0519-2010 | Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0520-2010 | Merit Medical Systems, Inc. Medallion Syringe REF/CAT No.: MSS111-LB Indicated for use…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0521-2010 | Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0522-2010 | Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0523-2010 | Merit Medical Sysems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag…Potential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |
| Z-0524-2010 | Merit Medical systems, Inc, Convenience Kit REF/CAT no.: K09-07692 REVISION A , CUSTOM KITPotential sterility breach caused by excessive shipment damage. | 09/29/2009Terminated |