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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 Cover see related information
Date Initiated by Firm November 22, 2017
Create Date July 13, 2018
Recall Status1 Terminated 3 on July 22, 2020
Recall Number Z-2332-2018
Recall Event ID 80160
510(K)Number K961029  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, 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 D151871, D151961, D161861, D162001, and D162911
Recalling Firm/
1 Ecolab Pl
Saint Paul MN 55102-2739
For Additional Information Contact Roman Blahoski
Manufacturer Reason
for Recall
The incorrect IFU was shipped with the product.
FDA Determined
Cause 2
Labeling False and Misleading
Action The 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 Commerce 65 cases
Distribution US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = KILTEX CORP.