Kimberly-Clark Corporation: The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.

Agency Publication Date: September 20, 2012

Affected Products

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.

Lots AW916102A

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.

Lots AW916002A, AW916102D

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63001

Status: Resolved

Manufacturer: Kimberly-Clark Corporation

Manufactured In: United States

Units Affected: 2 products (277 units; 766 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lots AW916102A

Lots AW916002A, AW916102D