Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Inte
FDA device recall Z-1197-2010 · posted 2010-03-23 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- Reason for recall
- Molding defect in the valve body causes leaking.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LHI
- Quantity affected
- 3230 cases; 32300 units (10 units/case)
- 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,
- Date initiated
- 2010-02-10
- Date posted
- 2010-03-23
- Date terminated
- 2012-04-09
- Location
- Englewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 (K002705) | Baxa Corp. | 2001-03-28 |