Retiro De Equipo (Recall) de Device Recall Natura Durahesive Convatec Moldable Techonology PostOperative/Surgical System (57mm)

Recall

57936

Class 3

Z-1610-2011

2011-02-01

2011-03-08

Terminated

United States

2012-01-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97782

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.

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.