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U.S. Department of Health and Human Services

Class 2 Device Recall KimberlyClark MIC Safety PEG Kit Pull Type

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  Class 2 Device Recall KimberlyClark MIC Safety PEG Kit Pull Type see related information
Date Initiated by Firm June 22, 2010
Date Posted September 20, 2012
Recall Status1 Terminated 3 on February 07, 2013
Recall Number Z-2415-2012
Recall Event ID 63001
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product Kimberly-Clark MIC Safety 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.
Code Information Lots AW916102A
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information Contact Thomas Kozma, PhD
770-587-8393
Manufacturer 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.
FDA Determined
Cause 2		 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 277 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.
Total Product Life Cycle TPLC 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.
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