—#140980

Product

Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P 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 product code: NYU — Catheter, Hemodialysis, Implanted, Coated
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K123196
Affected lot / code info: Lot Numbers: 1425000092

Why it was recalled

Incorrectly packaged with a 90 degree bend at the distal tip

Root cause (FDA determination)

Packaging process control

Action the firm took

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: feedback.customerservice@Covidien.com/Distributor to (203) 492-7719 or email to: PalCathFCA@Covidien.com. Questions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.

Timeline

Recall initiated: 2015-10-14
Posted by FDA: 2015-11-24
Terminated: 2017-06-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140980. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.