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U.S. Department of Health and Human Services

Class 3 Device Recall ECOLAB MICROTEK Rolled Probe Cover

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 Class 3 Device Recall ECOLAB MICROTEK Rolled Probe Coversee related information
Date Initiated by FirmNovember 22, 2017
Create DateJuly 13, 2018
Recall Status1 Terminated 3 on July 22, 2020
Recall NumberZ-2333-2018
Recall Event ID 80160
510(K)NumberK961029 
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
ProductECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
Code Information Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721.
Recalling Firm/
Manufacturer		 ECOLAB INC
1 Ecolab Pl
Saint Paul MN 55102-2739
For Additional Information ContactRoman Blahoski
651-250-4385
Manufacturer Reason
for Recall		The incorrect IFU was shipped with the product.
FDA Determined
Cause 2		Labeling False and Misleading
ActionThe recalling firm issued letters dated November 21, 2017, informing the customer the incorrect IFU was shipped with the product and a correct version of the IFU is being provided with the letter. The consignee was requested to notify downstream customers to the user level and that a copy of the letter could be forwarded to enhance communication. A Recall Response Form was enclosed for completion to be returned via FAX or email as soon as possible. The letter also informs the consignee that the recalling firm will send additional replacement IFU's if they have product in inventory. For further questions, please call (651) 250-4385.
Quantity in Commerce65 cases
DistributionUS Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYO
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