Date Initiated by Firm | January 16, 2024 |
Date Posted | February 07, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1009-2024 |
Recall Event ID |
93792 |
510(K)Number | K103264 |
Product Classification |
Accessories, cleaning, for endoscope - Product Code FEB
|
Product | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water.
The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI. |
Code Information |
UDI-DI 04953170401473
Lots 36A, 37A, 38A
Affected product may have also been packaged within OER boxes (OER-Elite and OER-MINI) |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy Center Valley PA 18034-8229
|
For Additional Information Contact | Cynthia Ow 484-896-5000 |
Manufacturer Reason for Recall | Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis. |
FDA Determined Cause 2 | Process control |
Action | On January 16, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION letters.
Customers were instructed to immediately assess all MAJ-2318 at their facility to check the model and lot number. Customers were given detailed instructions on how to identify affected product, including for MAJ-2318 installed in the OER machine.
Please contact your Olympus customer service representative at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return any affected product.
Customers who have further distributed product should notify downstream accounts at once.
If you require assistance with identifying affected product, please contact the Olympus Technical Assistance Center at 1- 800-848-9024, option 1.
If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com. |
Quantity in Commerce | 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI |
Distribution | Domestic US distribution nationwide. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FEB
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