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.
FDA Recall Z-1197-2010 · Posted 2010-03-23
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Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeLHI
Date Initiated2010-02-10
Date Terminated2012-04-09
Product Quantity3230 cases; 32300 units (10 units/case)
Reason for Recall
Molding defect in the valve body causes leaking.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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