Z-1282-2025Class I
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm...
Abbott Medical / initiated 2025-02-13 / Open, Classified / root cause: manufacturing process
Smiths Medical ASD, Inc. began a recall of smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF... on . FDA classified it as Class I and gives the reason as "The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1282-2025
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Abbott Medical
- Product
- smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
- Product code
- LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
- Reason for recall
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Smiths 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 [email protected] 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 commerce
- 1695 units
- Distribution
- Worldwide distribution.
- Product codes and lots
- UDI/DI 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1277-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1278-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1279-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1280-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1281-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1282-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1283-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1284-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1285-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1286-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1287-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1288-2025 | Class I | Ongoing | Voluntary: Firm initiated |
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