CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
Palindrome Precision HSI Chronic Catheter Sport Pack/Ch recalled
Covidien is recalling Palindrome Precision HSI Chronic Catheter Sport Pack/Ch (Symmetrical Tip, Heparin Coating, distributed nationwide in the US. The recall was initiated on 15 Mar 2024 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-1634-2024
- FDA event ID
- 94266
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Mar 2024
- FDA classified
- 24 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 15 Mar 2024 | Recall initiated by company | |
| 24 Apr 2024 | Classified by FDA | +40 days |
| 1 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.
Questions about this recall
Is Palindrome Precision HSI Chronic Catheter Sport Pack/Ch (Symmetrical Tip, Heparin Coating recalled?
Yes. Covidien recalled Palindrome Precision HSI Chronic Catheter Sport Pack/Ch (Symmetrical Tip, Heparin Coating on 15 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1634-2024.
Why was it recalled?
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Which lots are affected?
GTIN: 20884521157733 Lot Number: 2318500118
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.
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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