Recall Z-1368-2024 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K45BTOL LCS1545TPOL LCS1845TPST LCS4K45TPOL LCS1570BTOL LCS1870BTST LCS4K70BTOL LCS1570TPOL LCS1870TPST LCS4K70TPOL
| Date | Mar 22, 2024 (initiated Jan 16, 2024) |
| Status | Open, Classified |
| Reason | Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU |
| Root cause | Under Investigation by firm |
| Action | Olympus issued Urgent Medical Device Corrective Action letter on 1/16/24 to the Distributor-OLYMPUS MEDICAL SYSTEMS CORP LOGITE Tokyo, Japan for distribution to their consignees. Letter states reason for recall, health risk and action to take: Our records indicate that your facility has purchased one or more of the affected InstaClear Sheaths. Olympus requests you to take the following actions: 1. Inspect your inventory and identify any devices with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Add a copy of t |
| Quantity | 102,279 units (OUS Only) |
| Distribution | International distribution to the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152531 | InstaClear Lens Cleaner Gyrus Acmi, Inc., Jan 15, 2016 |