Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Mod
FDA device recall Z-0617-2024 · posted 2023-12-22 · Open, Classified
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FEB
- Quantity affected
- 2545 US; 992 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia Canada China Hong Kong Italy Malaysia Netherlands New Zealand Singapore Thailand
- Date initiated
- 2023-11-13
- Date posted
- 2023-12-22
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Advantage Plus Pass-Thru (K172677) | Medivators, Inc. | 2017-12-19 |
| MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR (K102996) | Medivators Reprocessing Systems | 2011-01-13 |
| MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT (K082988) | Medivators Reprocessing Systems | 2009-02-13 |