FDA Medical Device Recalls (openFDA)
Vitrolife, Inc.: 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.
- Recall number
- Z-2795-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-05-12
- Posted
- 2011-07-12
- Terminated
- 2011-07-15
- Reason
- Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.
- 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
- 1457 bottles
- Distribution
- Worldwide distribution including USA and Europe.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K081997"]
- PMA numbers
- not on file
- Product code
- MSB
- Firm FEI
- 3003274090
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28