Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney,
FDA device recall Z-0427-2011 · posted 2010-11-22 · Terminated
Recall details
- Recalling firm
- Preservation Solutions Inc
- Reason for recall
- Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.
- Action taken
- Bridge to Life, Ltd, issued a Notification of Product Recall letter dated October 18, 2010 to all direct accounts identifying the affected product and labeling issue. Customers were informed that all product from the affected lot has been replaced by the firm. Customers with questions about this recall can contact Bridge to Life at 803 673-4548..
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KDN
- Quantity affected
- 55 units
- Distribution
- Nationwide Distribution - in US to the states of CA, MO, and PA.
- Date initiated
- 2010-09-24
- Date posted
- 2010-11-22
- Date terminated
- 2012-04-02
- Location
- Elkhorn, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COSTORSOL (K073693) | Preservation Solutions, Inc. | 2008-07-03 |