Owens & Minor (NYSE:OMI) company ArcRoyal issued an urgent field safety notice in Europe to warn of an issue with ethylene oxide (EtO) residue in custom procedure trays that contain an insufflation tubing set with gas from Karl Storz.
Karl Storz initiated the recall, noting that the affected products contained increased residues of the carcinogenic sterilant gas at the time of delivery because a validation parameter had not been monitored, according to the safety notice. The tubing sets had been placed in ArcRoyal’s custom procedure trays.
Karl Storz said that there is no risk to future patients from unnecessary contact with the tubing set. Because of the short duration of the application and the low expected EtO exposure, no further measures are required for patients who have already been treated, the company added.
Users of the trays are urged to check inventory for affected product codes and remove the tubing set with the code 10-005212. That set can be returned to ArcRoyal or disposed of.
The affected products are listed below:
- GE1499 674165 W-028719 12 60 30/04/2021
- GE1499 674659 W-028719 4 20 30/04/2021
- GE1499 675281 W-028719 4 20 30/04/2021
- GE1499 676468 W-028719 8 40 30/05/2021
- GE1499 678015 W-028719 4 20 30/05/2021
- GE1499 679048 W-028707 4 20 30/07/2021
- GE1499 680201 W-028707 12 60 30/07/2021
- GE1513 678153 W-028707 4 16 30/07/2021
- NL0180 677704 W-028719 4 20 06/11/2021
- NL0180 678668 W-028707 8 40 25/11/2021
- NL0183 676563 W-028719 12 72 23/10/2021
- W-028719
- NL0183 677705 W-028707 12 72 11/11/2021
- NL0183 679914 W-028707 12 72 14/11/2021
- NL0183 681365 W-028707 8 48 08/12/2021
- NL0183 682790 W-028707 4 24 10/12/2021