Z-1883-2015Class II
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
Medtronic, Inc. / initiated 2015-04-23 / Terminated / root cause: manufacturing process
Covidien LLC began a recall of Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458 on . FDA classified it as Class II and gives the reason as "Catheters may not meet antimicrobial specification". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1883-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- Product
- Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
- Product code
- NYU Catheter, Hemodialysis, Implanted, Coated
- Reason for recall
- Catheters may not meet antimicrobial specification
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878. For questions regarding this recall call 203-492-5000.
- Quantity in commerce
- 72,363 US - 24,631 Internationally
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.
- Product codes and lots
- Item codes identified with an expiry date of February 2018 and earlier
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1850-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1851-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1852-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1853-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1854-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1857-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1858-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1859-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1860-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1861-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1862-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1863-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1864-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1865-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1866-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1867-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1868-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1869-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1870-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1871-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1872-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1873-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1874-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1875-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1876-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1877-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1878-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1879-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1880-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1881-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1882-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1883-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1884-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1885-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1886-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1887-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1888-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1889-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1890-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1891-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1892-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1893-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1894-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1895-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1896-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1897-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1898-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1899-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1900-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1901-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1902-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1903-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1904-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1905-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1906-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1907-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1908-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1909-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1910-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1911-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z1855-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z1856-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.