Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
FDA device recall Z-1851-2015 · posted 2015-07-01 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Catheters may not meet antimicrobial specification
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NYU
- Quantity affected
- 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, Ho
- Date initiated
- 2015-04-23
- Date posted
- 2015-07-01
- Date terminated
- 2017-07-26
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALINDROME H, SI, HSI CHRONIC CATHETER (K112477) | Covidien | 2011-09-28 |
| KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) (K060972) | Kendall | 2006-08-04 |