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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 30, 2016
Create DateDecember 14, 2016
Recall Status1 Terminated 3 on August 21, 2019
Recall NumberZ-0753-2017
Recall Event ID 75826
510(K)NumberK882724 
Product Classification Drape, surgical - Product Code KKX
ProductEcolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
Code Information 15302
Recalling Firm/
Manufacturer		 Ecolab Inc
370 Wabasha St N
Saint Paul MN 55102-1323
For Additional Information ContactRoman Blahoski
651-250-4385
Manufacturer Reason
for Recall		The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.
FDA Determined
Cause 2		Incorrect or no expiration date
ActionEcolab sent an "Urgent Medical Device Recall" letter dated November 30, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to quarantine the product for return. If the product was further distributed notify them of the recall. Requested customers to complete and return the Recall Response Form. For questions contact Customer Service by phone at 1-800-824-3027 or e-mail customerservice@microtekmed.com. For further questions please call (651) 250-4385.
Quantity in Commerce40 cases (144 eaches per box)
DistributionUS Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..
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 = KKX
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