Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095
This recall has been terminated (originally issued January 13, 2009).
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- September 12, 2008
- Posted
- January 13, 2009
- Terminated
- January 13, 2009
- Recall Number
- Z-0578-2009
- Quantity
- 399 kits
- Firm Location
- Jordan, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.
Distribution
United States including the states of AR, AZ, CA, CO, FL, KY, IL, IN, MA, MI, MN, MO, NJ, NY, PA, SC, TX, UT, VA, WI, and WV. No military or foreign distribution. VA facilities in CA and FL.
Lot / Code Info
Lot number F622787
Root Cause
Process control
Action Taken
All consignees were notified by sales reps via phone, fax or visit between 09/15/2008 and 10/09/2008. Sales reps were to instruct them to immediately discontinue use and quarantine all affected products. A Product Retrieval Form was to be completed and signed by the customer's site representative. More information available at 801-316-4998.