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
Collector, ostomy - Product Code EXB
원인
Natura durahesive convatec moldable technology post operative/surgical system (57mm) units may contain pouches with 45 mm natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together.
조치
Convatec sent a Medical Device Recall letter dated February 1, 2011, via UPS with return response forms attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to immediately stop distributing and quarantine the recalled lot (0100814).
Perform a count of recalled product currently in inventory.
Complete the enclosed Recall Response Form and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. Ensure that their account number is correctly identified on the attached Recall Response Form.
To return the recalled product call the toll free number 1-800-582-6514 to receive an RGA number and instructions on how and where to return the recalled product.
If the product has been distributed to wholesalers then customers should forward the letter to them and ask that they follow the Required Actions and return the Recall Response Form to the address listed on the form.
Product must be labeled for shipment to:
UPS Supply Chain Solutions
1920 Outer Loop
Dock Door #123
Louisville, KY 40219
For questions regarding this recall call 908-904-2149.
Nationwide Distribution including AZ, IL, KS, MA, MI, NC, OK, OR, PA, SC, and TX.
제품 설명
Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch || This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery.