Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.

FDA Recall Z-0938-2012 · Posted 2012-02-02

Recalling FirmKimberly-Clark Corporation
Recall StatusTerminated
Product CodeKNT
Date Initiated2011-12-21
Date Terminated2012-07-02
Product Quantity50 devices

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.

Firm Action

Kimberly-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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K852707GASTRO-ENTEROSTOMY TUBEMedical Innovations Corp. · 1985-08-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑