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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87596

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 17, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra LifeSciences Corp.

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

1 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 1

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

Z-1354-2021
Recall number
Z-1354-2021
Initiated
March 17, 2021
Classification
Class II
Status
Terminated
Quantity
49 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect labeling, Catheter did not have the required holes and markings

Code information

Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205

Distribution pattern

CA CO FL KY MD NC NC NY NY TX WI