CLASS II ONGOING Device recall · Reported 8 Sep 2021 · FDA Enforcement Report
Palindrome Precision RT Chronic Catheter Kit Symmetrical recalled
Covidien is recalling Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled/Ch. The recall was initiated on 28 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2371-2021
- FDA event ID
- 88250
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2021
- FDA classified
- 27 Aug 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 28 May 2021 | Recall initiated by company | |
| 27 Aug 2021 | Classified by FDA | +91 days |
| 8 Sep 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Product as listed by the FDA
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled/Ch recalled?
Yes. Covidien recalled Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled/Ch on 28 May 2021. The recall is Class II and its status is Ongoing. Recall number Z-2371-2021.
Why was it recalled?
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Which lots are affected?
Lot Numbers: 1724200116 1815000199 1921300032 1932300191 1725600107 1815800076 1921300034 1932300192 1727100076 1817100090 1927500067 2023300141 1728600062 1817700206 1929400086 2027200174 1734700104 1826800141 1929500067 2026000073 1801000128 1831600197 1929500068 2028200214 1802400119 1833100112 1929500071 2028200215 1804000126 1905600140 1929500088 2033100065 1805200078 1906000165 1929500089 2032800041 1806600074 1908400286 1929500072 2034400102 1807300167 1906700185 1930900073 1808600066 1920500223 1930900074
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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