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U.S. Department of Health and Human Services

Class 2 Device Recall Convatec EsteemBody

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  Class 2 Device Recall Convatec EsteemBody see related information
Date Initiated by Firm February 19, 2024
Date Posted March 21, 2024
Recall Status1 Open3, Classified
Recall Number Z-1350-2024
Recall Event ID 94121
Product Classification Bag, drainage, with adhesive, ostomy - Product Code FON
Product 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
Code Information a) 423643, UDI/DI 768455203925, Lot Numbers 3L03391; b) 423658, UDI/DI 768455204076, Lot Numbers 3L04005; c) 423659, UDI/DI 768455204083, Lot Numbers 3L03670; d) 423664, UDI/DI 768455204137, Lot Numbers 3L02230; e) 423666, UDI/DI 768455204151, Lot Numbers 3L04004; f) 423645, UDI/DI 976845520394, Lot Numbers 3L04989; g) 423667, UDI/DI 768455204168, Lot Numbers 3L04674; h) 423657, UDI/DI 768455204069, Lot Numbers 3L04114; i) 423652, UDI/DI 768455204014, Lot Numbers 3L03669; j) 423646, UDI/DI 768455203956, Lot Numbers 3M01542; k) 423654, UDI/DI 768455204038, Lot Numbers 3M00021; l) 423653, UDI/DI 768455204021, Lot Numbers 3M00786; m) 423647, UDI/DI 768455203963, Lot Numbers 3M01540; n) 423644, UDI/DI 768455203932, Lot Numbers 3M01539; o) 423648, UDI/DI 768455203970, Lot Numbers 3M01541; p) 423665, UDI/DI 768455204144, Lot Numbers 3M00029; q) 423656, UDI/DI 768455204052, Lot Numbers 3L00958; r) 423651, UDI/DI 768455204007, Lot Numbers 3K03888; s) 423660, UDI/DI 768455204090, Lot Numbers 3M00022; t) 423661, UDI/DI 768455204106, Lot Numbers 3M00023
Recalling Firm/
Manufacturer		 ConvaTec, Inc
7815 National Service Rd Ste 600
Greensboro NC 27409-9403
For Additional Information Contact media relations
336-547-3730
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 6709 units
Distribution Worldwide distribution - US Nationwide and the countries of Italy, UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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