XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH o
FDA device recall Z-2795-2011 · posted 2011-07-12 · Terminated
Recall details
- Recalling firm
- Vitrolife, Inc.
- Reason for recall
- Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.
- Action taken
- XVIVO Perfusion, part of the Vitrolife Group, sent out a "Partial recall of Perfadex with THAM" letter on May 13, 2011 to all affected customers. Customers were instructed to to quarantine all Perfadex with THAM. Replacement THAM was to be shipped by Vitrilife within a few days and the exchanged THAM was to immediately sent to Vitrolife, Englewood, CO. For additional Information please call (303) 762-1933
- Root cause
- Process control
- Status
- Terminated
- Product code
- MSB
- Quantity affected
- 1457 bottles
- Distribution
- Worldwide distribution including USA and Europe.
- Date initiated
- 2011-05-12
- Date posted
- 2011-07-12
- Date terminated
- 2011-07-15
- Location
- Englewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERFADEX WITH THAM (K081997) | Vitrolife Sweden AB | 2008-10-09 |