U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Ostomy care kit - Product Code PQE
원인
A portion of lot 7h02242 outer boxes (market units) of the sur-fit natura moldable durahesive skin barrier (10 pack, 45 mm, ref 411802) were incorrectly labeled as natura moldable stomahesive
skin barrier (10 pack, 45 mm, ref 411803).
조치
Customers were notified of the recall via Urgent: Voluntary Medical Device Recall letters on approximately 10/26/2017. The letter identified the affected device and the reason for the recall. The letter also provided instructions for distributors, retailers, and end users. End Users are to 1.) Inspect all shippers of 411802 (Durahesive), and all loose market units of 411803 (Stomahesive) to confirm whether affected product is under their control; 2.) Perform a count of affected product currently in inventory and complete and return the enclosed response form to the address provided; 3.) If customers have any affected product in inventory they are to contact cic@convatec.com or call the Customer Interaction Center at the toll free number 1-800-422-8811 for further instructions regarding how to return affected product and receive correctly labeled replacement product.
Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.
제품 설명
SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. || Intended for use as an ostomy protector providing a protective barrier to patient skin.