Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661
FDA Recall Z-1350-2024 · Posted 2024-03-21
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Recalling FirmConvaTec, Inc
Recall StatusOpen, Classified
Product CodeFON
Date Initiated2024-02-19
Product Quantity6709 units
Reason for Recall
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
Firm Action
ConvaTec issued an URGENT: VOLUNTARY MEDICAL DEVICE RECALL notice to its consignees on 02/19/2024 via email. The notice explained the problem and requested the consignee quarantine the affected product and respond. Upon receipt, the firm will issue a Certificate of destruction and request the destruction of the product.
The notice be shared with the correct individual with the organization and disseminated to all who need to be aware and distributors were directed to notify their customers.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Italy, UK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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