Recall Z-0521-2010
Merit Medical Systems, Inc. · initiated September 29, 2009
Product
Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.
Codes / lots: Lot #9H4824
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-0521-2010
- Initiated
- September 29, 2009
- Posted by FDA
- December 14, 2009
- Terminated
- December 15, 2009
- Product code
- KGZ – Accessories, Catheter
- Quantity
- 5 fixation devices
- 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-0515-2010 | Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with…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-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 |