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Class 2 Device Recall CLEANER BOTTLE |
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Date Initiated by Firm |
March 13, 2024 |
Date Posted |
April 24, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1686-2024 |
Recall Event ID |
94293 |
510(K)Number |
K190124
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Product Classification |
Scaler, ultrasonic - Product Code ELC
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Product |
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
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Code Information |
Lot Code: Model number: EG-1000, UDI: 07613353180225, Lot number: 16442-210, Expiry date: 2026-04.
AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148
AIRFLOW ONE UDI-DI code: 07613353184124
Product Serial Numbers:
KU23665
KU23668
KU23669
KU23670
KU23671
KU23673
KU23674
KU23675
KU23676
KU23677
KU23679
KU23680
KU23681
KU23682
KU23683
KU23684
KU23685
KU23687
KU23690
KU23691
KU23692
KU23693
KU23694
KU23695
KU23696
KU23697
KU23698
KU23699
KU23702
KU23704
KU23705
KU23707
KU23708
KU23709
KU23710
KU23711
KU23712
KU23713
KU23714
KU23715
KU23717
KU23718
KU23720
KU23721
KU23723
KU23724
LD05012
LD05033
LD05034
LD05035
LD05036
LD05037
LD05100
LD05101
LD05102
LD05103
LD05104
LD05105
LD05106
LD05107
LD05108
LD05109
LD05110
LD05111
LD05112
LD05113
LD05114
LD05115
KU23666
KU23667
KU23672
KU23678
KU23686
KU23688
KU23689
KU23700
KU23701
KU23703
KU23706
KU23722
KU24328
KU24341
KU23716
KU23719
KU24342
KU24343
KU24344
KU24345
KU24346
KU24347
KU24348
KU24349
KU24350
KU24351
LD05116
LD05117
LD05118
LD05119
LD05120
LD05121
LD05122
LD05513
LD05514
LD05516
LD05517
LD05518
LD05519
LD05520
LD05521
LD05522
LD05523
LD05524
LD05525
LD05526
LD05527
LD05528
LD05529
LD05530
LD05531
LD05532
LD05533
LD05534
LD05535
KU21778
KU21884
KU21915
KU21948
KU21972
KU22135
KU22136
KU22137
KU22138
KU22139
KU22140
KU22141
KU22142
KU22143
KU22146
KU22147
KU22165
KU22166
KU22167
KU22168
KU22169
KU22170
KU22171
KU22172
KU22173
KU22174
KU22175
KU22176
KU22177
KU22178
LD05038
LD05039
LD05041
LD05042
KU21767
KU21990
KU21991
KU22592
KU23365
KU23366
KU23367
KU23368
KU23369
KU23370
KU23371
KU23372
KU23373
KU23374
KU23375
KU23376
KU23378
KU23379
KU23381
KU23382
LD05093
LD05536
LD05094
LD05095
LD05096
KU23023
KU23026
KU23027
KU23029
KU23030
KU23031
KU23032
KU23064
KU23112
KU23119
KU23120
KU23123
KU23128
KU23131
KU23132
KU23252
KU23263
KU23264
KU23265
KU23266
KU23267
KU23268
KU23269
KU23270
KU23271
KU23272
KU23273
KU23275
KU23276
KU23277
KU23278
KU23279
KU23280
KU23281
KU23282
KU23283
KU23284
KU23289
KU23294
KU23305
LD05537
LD05097
LD05098
LD05099
LD05538
LD05539
LD05540
LD05541
LD05542
KU25788
KU25789
KU25790
KU25791
KU25792
KU25793
KU25794
KU25795
KU25796
KU25797
KU25798
KU25799
KU25800
KU25801
KU25802
KU25803
LD05607
LD05664
LD05665
LD05666
LD05667
LD05668
LD05669
LD05670
LD05671
LD05672
LD05673
LD05674
LD05675
LD05676
LD05677
LD05678
KU25758
KU25759
KU25760
KU25761
KU25762
KU25763
KU25764
KU25765
KU25766
KU25767
KU25768
KU25769
KU25770
KU25771
KU25772
KU25773
LD05679
LD05680
LD05681
LD05682
LD05683
LD05684
LD05685
LD05686
LD05687
KU26136
KU26140
KU26141
KU26142
KU26143
KU26144
KU26145
KU26146
KU26155
KU26846
KU26968
KU26969
KU26970
KU26971
KU26972
KU26973
KU26974
KU26975
KU26976
KU26977
KU26978
KU26979
KU26980
KU26981
KU26091
KU26094
KU26097
KU26168
LD05723
LD05724
LD05725
LD05726
LD05727
KU26205
KU26206
KU26218
KU26219
KU26220
KU26221
KU26222
KU26223
KU26224
KU26225
KU26226
KU26227
KU26228
KU26229
KU26230
KU26231
KU26281
KU26284
KU26285
KU26289
EG-1000A x1 OF-99-12848-1
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Recalling Firm/ Manufacturer |
Electro Medical Systems SA Chemin De La Vuarpilliere 31 Nyon Switzerland
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For Additional Information Contact |
Alfred Gonzales 972-6908382
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Manufacturer Reason for Recall |
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
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FDA Determined Cause 2 |
Process control |
Action |
On 3/13/2024, the firm notified, via email, its distributors and asked them to extend the recall to end users. Currently the Customer Notification Letter to end users is being drafted (date of distribution pending).
The Customer Notification Letter will information customers that the firm is recalling WATER, CLEANER and PIEZON Bottles due to a manufacturing issue that may result with these affected bottles to leak and/or break and in unfavorable cases may lead to injuries.
Customers are instructed to:
1. Cease use of the affected products.
2. Return the affected products to their distributors
For questions or assistance, contact EMS Dallas at 1-800-367-0367 or email to emsrepairs@ems-na.com Monday thru Friday 8:00 a.m. to 5:00 p.m. CST. |
Quantity in Commerce |
342 |
Distribution |
Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of
ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM. |
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 = ELC and Original Applicant = E.M.S Electro Medical Systems S.A.
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