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.
This recall has been terminated (originally issued September 20, 2012).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- June 22, 2010
- Posted
- September 20, 2012
- Terminated
- February 7, 2013
- Recall Number
- Z-2416-2012
- Quantity
- 766 units
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lots AW916002A, AW916102D
Root Cause
Nonconforming Material/Component
Action Taken
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.