Data Foundry

Medical device recalls 2023

Palindrome Chronic Catheter Kit Symmetrical Tip14 — Class II medical device recall Z-2632-2023

Ongoing recall by Covidien LP, reported 2023-10-04, distributed nationwide. Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the

Recall numberZ-2632-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCovidien LP, Mansfield, MA, United States
Recall initiated2023-08-22
Classified2023-09-25
Reported by FDA2023-10-04
DistributedNationwide (US)
Countries outside the USAT, BE, BR, CN, CZ, DE, ES, FI, FR, GB, IT, NL, NO, PL, PT, TH
Quantity3,050 devices
Reason classeslabeling
UPC / GTIN / UDI-DI10884521013162, 20884521013169
Lot numbers2221700131, 2224200233, 2230400271, 2230400272

Product

Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm

Reason for recall

Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.

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-2632-2023. 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.