Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Reported: October 4, 2023 Initiated: August 22, 2023 #Z-2632-2023
Product Description
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Reason for Recall
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
Details
- Recalling Firm
- Covidien LP
- Units Affected
- 3050 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Thailand, United Kingdom.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm. Recalled by Covidien LP. Units affected: 3050 devices.
Why was this product recalled? ▼
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 4, 2023. Severity: Moderate. Recall number: Z-2632-2023.
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