FDA Device Recall Z-0329-2016: Covidien LLC

Recall Res Number

Z-0329-2016

Recalling Firm / Manufacturer

Covidien LLC

FEI Number

1219930

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2015-10-14

Date Posted

2015-11-24

Date Terminated

2017-06-02

Product Code

NYU

Event Number

72416

Product Quantity

280 units

Product Description Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 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.

Reason for Recall Incorrectly packaged with a 90 degree bend at the distal tip

Action Details 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.

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

Code Information / Serial Numbers Lot Numbers: 1503500094, 1431900098, 1435800009

Covidien Registration: 1219930 View Registration
Covidien LLC Registration: 1282497 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Cardinal Health Costa Rica, S.A. Registration: 3009211636 View Registration
BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
MOZARC MEDICAL US LLC Registration: 3030574705 View Registration
Covidien Registration: 9610849 View Registration

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Medical Device Recall: Z-0329-2016

Recall Parameters & Description

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