Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P
FDA device recall Z-1885-2015 · 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
- MSD
- 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH (K123196) | Covidien | 2013-01-31 |
| 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 |