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Recall Observatory FDA recall evidence

Device product

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

Z-1634-2024

March 15, 2024

Class II

Product summary

Firm
Covidien LP
Event
Event 94266
Status
Ongoing
Classification
Class II
Quantity
305 units
Official record key
device-enforcement:Z-1634-2024

Official wording

Reason: 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

Code information: GTIN: 20884521157733 Lot Number: 2318500118

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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