Kimberly-Clark MIC Safety PEG Kit Recall Due to Guidewire Size Issue
Kimberly-Clark is recalling 277 units of MIC Safety PEG Kits 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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Kimberly-Clark Corporation is recalling 277 units of the MIC Safety PEG Kit - Pull Type. These devices are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The affected product is identified by lot number AW916102A.
The recall was initiated because the placement guidewire diameter is too large and does not pass through the introducer needle during the placement procedure. This defect prevents the proper execution of the intended placement technique.
The affected units were distributed nationwide, including to Alabama, Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin. Healthcare providers and facilities should stop using the affected lots and contact Kimberly-Clark for further instructions.
The recalled product
- 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
- Manufacturer
- Kimberly-Clark Corporation
- Affected units
- 277
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 (1)
- Lots AW916102A
Distribution
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.
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