Z-2795-2011

XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to...

Name: Z-2795-2011 XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to...
Creator: Vitrolife, Inc.
Published: 2011-05-12
License: https://open.fda.gov/license/

Vitrolife Inc. / initiated 2011-05-12 / Terminated / root cause: manufacturing process

FDA source

Vitrolife, Inc. began a recall of XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of... on 2011-05-12. The reason FDA records is "Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2795-2011
Status: Terminated
Initiated: 2011-05-12
Posted: 2011-07-12
Terminated: 2011-07-15
Recalling firm: Vitrolife Inc.
Product: XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.
Product code: MSB System And Accessories, Isolated Heart, Transport And Preservation
Reason for recall: Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 1457 bottles
Distribution: Worldwide distribution including USA and Europe.
Product codes and lots: Addex THAM 50, lot number 2570350. Relabeled and distributed as THAM, REF 99019, lots 502518, 502590, 502663, 502664, 502688, 502709, 502735, 502774, 502809, 502822, 502834. Perfadex with THAM kit, 8 x 1000mL REF 19017, 502522 (502518) 502591 (502590) 502662 (502664) 502689 (502688) 502734 (502735) 502807 (502809) 502835 (502834). (Number in parenthesis is THAM LOT number used in kit) Perfadex with THAM kit 2 x 2800mL REF 19018: 502521 (502518) 502663 (502664) 502708 (502709) 502743 (502774) 502808 (502809) 502823 (502822) 502826 (502822). (Number in parenthesis is THAM LOT number used in kit)

Product code MSB

K081997Class IIPerfadex with ThamVitrolife Sweden AB / cleared 2008-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)