Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
FDA Recall Z-0331-2016 · Posted 2015-11-24
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Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeNYU
Date Initiated2015-10-14
Date Terminated2017-06-02
Product Quantity365 units
Reason for Recall
Incorrectly packaged with a 90 degree bend at the distal tip
Firm Action
The firm, Medtronic (Covidien), sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/16/2015 to their customers. The letter described the product, problem, and actions to be taken. Customers were instructed to quarantine and discontinue use of the product, return affected product and complete and return the RECALLED PRODUCT RETURN FORM via Fax to Medtronic to (800)-895-6140 or email to: [email protected]/Distributor to (203) 492-7719 or email to: [email protected].
Questions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878.
Root Cause
Packaging process control
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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