Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management

FDA Recall Z-0233-2020 · Posted None

Recalling FirmConvaTec, Inc
Recall StatusTerminated
Product CodeEXE
Date Initiated2019-09-06
Date Terminated2022-11-30
Product Quantity8,008131 skin barriers

Reason for Recall

ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.

Firm Action

The firm began notifying their consignees by telephone on 09/06/2019 and followed with a letter on 09/11/2019. The letter identifies the products and lots involved, describes the problem and states that Convatec will accept product returns of affected product.

Root Cause

Process control

Distribution Pattern

Worldwide distributions.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑