Z-2416-2012Class II

Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous...

Name: Z-2416-2012 Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous...
Creator: Kimberly-Clark Corporation
Published: 2010-06-22
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2010-06-22 / Terminated / root cause: manufacturing process

FDA source

Kimberly-Clark Corporation began a recall of Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a... on 2010-06-22. FDA classified it as Class II and gives the reason as "The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2416-2012
Classification: Class II
Status: Terminated
Initiated: 2010-06-22
Posted: 2012-09-20
Terminated: 2013-02-07
Recalling firm: Kimberly-Clark Corporation
Product: Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Kimberly-Clark Health Care sent an Urgent Voluntary Medical Device Withdrawal letter dated June 22, 2010, to all affected customers. The letter included a Product Withdrawal Response Sheet which was to be returned to Kimberly-Clark. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and destroy all affected products and complete the attached Product Withdrawal Response Sheet and Fax the form to 920-225-4182. For questions customers should call 770-587-7362. For questions regarding this recall call 770-587-8393.
Quantity in commerce: 766 units
Distribution: Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
Product codes and lots: Lots AW916002A, AW916102D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2416-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2415-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2416-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code KNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)