Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following mode
FDA device recall Z-1018-2015 · posted 2015-02-03 · Terminated
Recall details
- Recalling firm
- Covidien
- Reason for recall
- A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal.
- Action taken
- Consignees were sent an Urgent Product Recall letter dated 12/15/2014. The letter described the issue, identified the affected product, and the required actions. Affected product was to be returned directly to customers' Covidien Sales Rep; or customers were to contact Covidien Service at 1-800-716-6700 to arrange for product return. Questions can be directed to the Covidien Sales Rep or to Covidien Service at 1-800-716-6700. Customers were to complete and return the Verification Form along with the unused product as soon as possible.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 1032 devices (919 US, 113 OUS)
- Distribution
- Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Date initiated
- 2014-12-10
- Date posted
- 2015-02-03
- Date terminated
- 2016-03-31
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRELLIS-8 PERIPHERAL INFUSION SYSTEM (K130904) | Covidien | 2013-10-25 |