Volume 11, No. 4 • Winter 1996

Sevo Manufacturer Outlines Circumstances, Response

Clair M. Callan, M.D.

To the Editor

Abbott appreciates the cooperation received from Dr. Leary and Glen Falls Hospital related to the recall of Ultane (sevoflurane) lot number 10-590-DK. This spirit of cooperation has been extended by other U.S. hospitals related to the recall, as well as North American Drager and Ohmeda. By working cooperatively and expeditiously, we were all able to act in the best interest of patient safety.

We are extremely pleased that there were no reports of patient involvement associated with acidic sevoflurane. The review of anesthesia records at Glen Falls is consistent with Abbott records of adverse drug event reports–there has been no report of patient injury.

As Dr. Leary indicated, Abbott initiated the single-lot recall on November 18th. An overnight letter was sent to all customers of record who purchased lot 10-590-DK direct from Abbott. Abbott also was able to assist with the rapid notification to indirect customers who purchased this recalled lot through wholesalers and distributors. Complete notification to customers was achieved very rapidly. In addition, Abbott sent a letter notifying all directors of anesthesia and directors of pharmacy of the recall to insure that non-purchasers of the specific lot were aware of the issue.

Glens Falls Hospital took an appropriate precautionary step by taking the anesthesia equipment out of service. Based on data collected from returned bottles, Abbott determined that acidic Ultane had been present in 18 hospitals and was found in vaporizers in five of those hospitals. This acidic Ultane was found in lot 10-590-DK only.

Abbott contacted all accounts that had acidic sevoflurane. Those with acidic sevoflurane in a vaporizer were instructed to take the anesthesia machines and vaporizers out of service for testing. Testing of equipment exposed to hydrofluoric acid (HF) performed by Abbott and independent consultants has shown no impact on the equipment. Abbott, in cooperation with Ohmeda and North American Drager, has developed testing protocols to further explore the question regarding vaporizer performance. Abbott expects these tests will confirm earlier findings that HF has no impact.

Abbott is in the process of implementing manufacturing improvements to ensure that the conditions that precipitated this recall are not repeated. Additionally, tests of manufacturing samples and of other lots in the field demonstrate Ultane is safe for continued use. Abbott is grateful to its customers, including Dr. Leary, North American Drager and Ohmeda for their cooperation and attention in executing this recall. If anyone has specific questions regarding this recall, they should contact the Abbott Medical Department at (800) 615-0187.

Clair M. Callan, M.D. Hospital Product Division Abbott (Abbott Park, IL)