The Recall Desk
ModerateFDA (Devices)·Z-2416-2012·Announced 2012-09-26

Kimberly-Clark MIC PEG Kit Recall Due to Placement Guidewire Size Issue

Kimberly-Clark is recalling MIC PEG Kits - Pull Type because the placement guidewire is too large to pass through the introducer needle.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Kimberly-Clark Corporation is recalling 766 units of the MIC PEG Kit - Pull Type. These are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique, held in place during use with an external retention disk.

The recall is due to a defect where the placement guidewire diameter is too large and does not pass through the introducer needle during the placement procedure. The affected lots are AW916002A and AW916102D.

The product was distributed nationwide, including in 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. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected kits.

The recalled product

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.
Manufacturer
Kimberly-Clark Corporation
Category
Medical Device — Gastrostomy Tubes
Hazard
Affected units
766

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lots AW916002A
  • AW916102D

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Kimberly-Clark Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same manufacturer · Kimberly-Clark Corporation

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