Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 42
FDA device recall Z-1350-2024 · posted 2024-03-21 · Open, Classified
Recall details
- Recalling firm
- ConvaTec, Inc
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FON
- Quantity affected
- 6709 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, UK.
- Date initiated
- 2024-02-19
- Date posted
- 2024-03-21
- Location
- Greensboro, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.