Data Foundry

Medical device recalls 2024

Palindrome Precision H Chronic Catheter Kit 14 — Class II medical device recall Z-1635-2024

Ongoing recall by Covidien LP, reported 2024-05-01, distributed nationwide. Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the a

Recall numberZ-1635-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCovidien LP, Mansfield, MA, United States
Recall initiated2024-03-15
Classified2024-04-24
Reported by FDA2024-05-01
DistributedNationwide (US)
Countries outside the USAT, BE, DE, DK, ES, FR, GB, GR, IE, IS, IT, NO, PL, SE, ZA
Quantity878 units
Reason classeslabeling
UPC / GTIN / UDI-DI10884521158085, 20884521158082
Lot numbers2201700103, 2228000074, 2228000089
Model numbers8888145044CP

Product

Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP

Reason for recall

Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

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-1635-2024. 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.