Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm recall: Contamination
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
Why was Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm recalled?
Catheters may not meet antimicrobial specification
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item codes identified with an expiry date of February 2018 and earlier
- Product
- Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
- Recalling firm
- Covidien LLC
- Quantity
- 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.
- Recall date
- July 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)