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U.S. Department of Health and Human Services

Class 1 Device Recall Deltec ProPort

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 Class 1 Device Recall Deltec ProPortsee related information
Date Initiated by FirmFebruary 13, 2025
Date PostedMarch 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1281-2025
Recall Event ID 96294
510(K)NumberK994216 
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Productsmiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Code Information UDI/DI 10610586012594, Lot Numbers: 3926119, 3928191, 3944833, 3960347, 3968098, 3988451, 4027913, 4057817, 4087000, 4139520, 4146467, 4173474, 4196758, 4221725, 4235599, 4256939, 4291484, 4295931, 4302979, 4307473, 4307474, 4437254, 4447572, 4449876, 4460619, 6037144, 6006017, 6059285, 6026682, 6062025, 6071258.
FEI Number 3012307300
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactCustomer Service
800-258-5361
Manufacturer Reason
for Recall		The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
FDA Determined
Cause 2		Process control
ActionSmiths medical issued an URGENT MEDICAL DEVICE RECALL to its consignees on 02/13/2025 via letter delivered by traceable means. The notice explained the issue, potential risk, and requested the following: Required Actions for Customers 1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Please return all affected product. 3. Inform all potential users of the product in your organization of this notification and complete and return the attached response form to smithsmedical8171@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product and/or has already been used. 4. If you have distributed the product further, immediately notify your accounts that received the affected product and ask them to contact Sedgwick at 1-888-345-2656 (MF, 8am-5pm ET) to obtain a response form.
Quantity in Commerce3263 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LJT
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