Date Initiated by Firm |
December 07, 2023 |
Date Posted |
January 26, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0836-2024 |
Recall Event ID |
93625 |
510(K)Number |
K191021
|
Product Classification |
Indicator, physical/chemical sterilization process - Product Code JOJ
|
Product |
Terragene Integron IT26-C
Terragene Integron IT26-C with extender
Benco Dental Chemical Integrator [5726-583]
Tuttnauer (WTL198-0082)
Terragene Integron (PCD26-C)
Terragene Bionova PCD (PCD222-C) |
Code Information |
Product Number: IT26-C
UDI-DI code: 07798164679622
Lot Numbers:
19033
19038
19039
19040
19057
19105-12
19105-16
B10400-13
B10400-14
B10400-16
B10400-21
B10400-23
19105-23
19105-24
B10519
B10555
B10625
B10627
B10628
B10629
B20040
B20043
B30012
B30013
B30110
B30111
B30112
Product Number: IT26-C with extender
UDI-DI code: 07798164678656
Lot Numbers:
19059
B10572
B30068
B30110
Product Number: Terragene Integron (PCD26-C)
UDI-DI code: 07798164679370
Lot Numbers:
100320
110320
220620
F10009
F20026
F20079
F20084
Product Number: Benco Dental Chemical Integrator 5726-583
UDI-DI code: 00366975058768
Lot Numbers:
131120-8
131120-1
131120-2
131120-4
131120-7
131120-5
131120-11
131120-3
131120-16
131120-15
131120-12
131120-19
131120-10
131120-6
131120-18
131120-17
131120-14
131120-13
131120-9
B10540
B20039
B20185
B20576
B30010
B30138
Product Number: Tuttnauer (WTL198-0082)
UDI-DI code: 07798164677888
Lot Numbers:
120320
170920-3
170920-2
170920-1
170920-8
170920-7
170920-6
170920-5
170920-4
B10331-1
B10331-2
B10331-3
B10539
B20679 |
Recalling Firm/ Manufacturer |
TERRAGENE S.A. Ruta Nacional N 9, Km 280, Cp 2130 Parque Industrial Micropi Alvear Argentina
|
For Additional Information Contact |
Customer Service 844-8377243
|
Manufacturer Reason for Recall |
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
|
FDA Determined Cause 2 |
Labeling False and Misleading |
Action |
On 12/07/2023, the firm notified via email its initial importers/distributor a "Voluntary Recall Notification " that contained a "COMMUNICATION TO CUSTOMER VOLUNTARY RECALL OF PRODUCT/URGENT: MEDICAL DEVICE RECALL" Letter informing them of the discrepancies identified in the IFUs of some products that mentions extended cycles that may mislead users to think that these cycles are part of the FDA-cleared indications for use of the product.
Initial Importers/Distributors are instructed to send the following information to Terragene:
-Quantity in stock
-Quantity distributed
-Consignees
On or about 12/22/2023, the firm initiated distribution, via email, an "URGENT: MEDICAL DEVICE RECALL" Letter to customers (identified by their Initial Imports/Distributors) informing them of the Recall issue (discrepancy identified in the IFU) provide an updated IFU (version 4) correcting the issue. Customers are instructed to print the updated IFU and attach it to their remaining inventory, and to discard the older IFU versions (version 1 thru 3).
For questions or concerns, contact customer.service@terragene.com or www.terragene.com , or +1-844-837-7243 Monday thru Friday 6:00 AM to 3:00 PM, Eastern Time. |
Quantity in Commerce |
36,857 strips |
Distribution |
U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA. |
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 = JOJ and Original Applicant = Terragene SA
|