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U.S. Department of Health and Human Services

Class 2 Device Recall KIMBERLY CLARK MIC GASTROENTERIC FEEDING TUBE

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 Class 2 Device Recall KIMBERLY CLARK MIC GASTROENTERIC FEEDING TUBEsee related information
Date Initiated by FirmDecember 21, 2011
Date PostedFebruary 02, 2012
Recall Status1 Terminated 3 on July 02, 2012
Recall NumberZ-0938-2012
Recall Event ID 60900
510(K)NumberK852707 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductKIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.
Code Information Catalogue number: 0210-22, Lot number: AA1129E02
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information ContactThomas Kozma, PhD
770-587-7835
Manufacturer Reason
for Recall		The product is misbranded, i.e. the Gastric (center) port may be mislabeled as the Jejunal port, and the Jejunal (side) port mislabeled as the Gastric port.
FDA Determined
Cause 2		Labeling False and Misleading
ActionKimberly-Clark Health Care sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter and e-mail to all affected customers. The communications described the product, problem, and actions to be taken by the customers. Customers were instructed to locate and quarantine any affected product. A Product Recall Response Sheet was enclosed for customers to complete and return to the firm via fax at 920-380-6682. Contact the firm at 770-587-7400 for questions regarding this recall.
Quantity in Commerce50 devices
DistributionWorldwide Distribution-USA (nationwide) including the states of CA, CO, ID, IL, MD, MO, NC, NJ, NY, PA, SC, UT, VA, WA, WI, and WV and the country of Canada.
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 = KNT
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