Recall Z-0617-2024 ยท FEB Accessories, Cleaning, For Endoscope
Steris Corporation
Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION SCIENCE 2-8-112 ASSY, HOOKUP OLMPUS 1K 2-8-120 ASSY, HOOKUP FUJI 1K 2-8-210 ASSY, HOOK
| Date | Dec 22, 2023 (initiated Nov 13, 2023) |
| Status | Open, Classified |
| Reason | Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures. |
| Root cause | Process control |
| Action | On November 13, 2023, the firm notified customers via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to inspect their inventory for affected product. You should not attempt to use a hookup that cannot be effectively identified. Steris will provide either a replacement hookup or replacement label for all affected hookups. If you have questions regarding this matter, please contact Regulatory_Compliance@STERIS.com. |
| Quantity | 2545 US; 992 OUS |
| Distribution | Domestic distribution nationwide. Foreign distribution to Australia Canada China Hong Kong Italy Malaysia Netherlands New Zealand Singapore Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082988 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT Medivators Reprocessing Systems, Feb 13, 2009 |
| K102996 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR Medivators Reprocessing Systems, Jan 13, 2011 |
| K172677 | Advantage Plus Pass-Thru Medivators, Inc., Dec 19, 2017 |