Date Initiated by Firm |
December 04, 2023 |
Date Posted |
January 12, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0718-2024 |
Recall Event ID |
93629 |
510(K)Number |
K183647
|
Product Classification |
Powered laser surgical instrument - Product Code GEX
|
Product |
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS |
Code Information |
UDI-DI 00821925043985
Lot KR262848 |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy Center Valley PA 18034-8229
|
For Additional Information Contact |
Cynthia Ow 647-999-3203
|
Manufacturer Reason for Recall |
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On December 4, 2023, the firm notified affected customers via Urgent Medical Device Removal letters.
Customers were instructed to identify and quarantine the affected model/lot. Affected product should not be used. Olympus will issue a credit to customers upon the return of the affected product. If product was distributed outside the customer's facility, the customer should notify those outside facilities immediately.
If you require additional information, please contact the company by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com. |
Quantity in Commerce |
179 units |
Distribution |
Domestic distribution to the following states: AK
AR
AZ
CA
FL
GA
IA
ID
IN
KS
KY
LA
MA
MI
NC
ND
NE
NJ
NY
OR
PA
SC
SD
TN
TX
VA
WI
International distribution to Canada, Latin America, and Europe. |
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 = GEX and Original Applicant = Olympus Surgical Technologies America
|