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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0938-2012
Recalling firm
Kimberly-Clark Corporation
Product
KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.
Status
Terminated
Initiated
2011-12-21
Posted
2012-02-02
Terminated
2012-07-02
Reason
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.
Root cause
Labeling False and Misleading
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.
Quantity
50 devices
Distribution
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.
Lot, serial or model codes
Catalogue number: 0210-22, Lot number: AA1129E02
510(k) numbers
["K852707"]
PMA numbers
not on file
Product code
KNT
Firm FEI
1000015879
Firm city
Roswell
Firm state
GA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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