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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94266

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 15, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Covidien LP

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P

Z-1634-2024
Recall number
Z-1634-2024
Initiated
March 15, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien LP
Quantity
305 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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

Code information

GTIN: 20884521157733 Lot Number: 2318500118

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.

device · product 2 of 2

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

Z-1635-2024
Recall number
Z-1635-2024
Initiated
March 15, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Covidien LP
Quantity
878 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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

Code information

GTIN: 20884521158082, 10884521158085 Lot Number: 2228000089, 2201700103, 2228000074

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.