Data Foundry

Medical device recalls 2015

Palindrome Precision Chronic Catheter Kit Symmetrical Tip — Class II medical device recall Z-0331-2016

Terminated recall by Covidien LLC, reported 2015-12-02, distributed nationwide. Incorrectly packaged with a 90 degree bend at the distal tip

Recall numberZ-0331-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCovidien LLC, North Haven, CT, United States
Recall initiated2015-10-14
Classified2015-11-24
Reported by FDA2015-12-02
Terminated2017-06-02
DistributedNationwide (US)
Countries outside the USBE, CA, CH, CL, DE, DK, ES, FR, GB, NL, PA
Quantity365 units
Lot numbers1425000091, 1504700102, 1516900090
Model numbers8888145042P

Product

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.

Reason for recall

Incorrectly packaged with a 90 degree bend at the distal tip

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0331-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.