|
Class 2 Device Recall InstaClear Lens Sheath |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
April 03, 2024 |
Date Posted |
May 23, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1888-2024 |
Recall Event ID |
94545 |
510(K)Number |
K152531
|
Product Classification |
Nasopharyngoscope (flexible or rigid) - Product Code EOB
|
Product |
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
|
Code Information |
Model No. LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL; UDI-DI: 00821925040137, 00821925040151, 00821925040144, 00821925040175, 00821925040168, 00821925040199, 00821925040182, 00821925040083, 00821925040076, 00821925040106, 00821925040090, 00821925040120, 00821925040113, 00821925040069; All Lot Numbers. |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy Center Valley PA 18034-8229
|
For Additional Information Contact |
Cynthia Ow 647-9993203
|
Manufacturer Reason for Recall |
Potential for distal end of the sheath to break off during a procedure.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notification, dated 5/1/24. Consignees are instructed to read the provided labeling addendum, inspect their inventory to identify affected devices and place a copy of the addendum with the remaining inventory, ensure all required personnel are aware of this recall, notify those who received product further distributed, and acknowledge receipt of the recall notification using Olympus's recall portal. Consignees can report the incidence of a device breakage associated with this event to the Technical Assistance Center at 1-800-8489024, Option 1. Consignees with any questions can contact Olympus at 647-999-3203 or by email at Cynthia.Ow@olympus.com. |
Quantity in Commerce |
pending |
Distribution |
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = EOB and Original Applicant = GYRUS ACMI, INC.
|
|
|
|