Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-2416-2012 |
| Classification | Class II |
| Code Info | Lots AW916002A, AW916102D |
| Product Distributed Qty | 766 units |
| 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. |
Event Detail
| Event Id | 63001 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Kimberly-Clark Corporation |
| City | Roswell |
| State | GA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2010-06-22 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | 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. |
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