Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up to 24 source ingredients.
This recall has been terminated (originally issued March 23, 2010).
- Company
- Baxa Corporation
- Recall Initiated
- February 10, 2010
- Posted
- March 23, 2010
- Terminated
- April 9, 2012
- Recall Number
- Z-1197-2010
- Quantity
- 3230 cases; 32300 units (10 units/case)
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Molding defect in the valve body causes leaking.
Distribution
Nationwide Distribution -- Including AL, AR, AZ, CA, CO, DC, MN, IL, NY, DE, FL, PA, IN, TN, MS, MO, TX, MI, MA, MT, MO, SC, VA, WV, NJ, OH, CT, MO, NV, LA, WA, WI, GA, OK, NE, NH, NC, MD, KS, UT, IA, KY, HI, OR, SC, ME and SD.
Lot / Code Info
Model number: 724, Lot Numbers: 740789 through 742707 (sequentially numbered).
Root Cause
Nonconforming Material/Component
Action Taken
Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm. For further information, contact Baxa Corporation at 1-303-617-2242.
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