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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94622

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

Open FDA event record

Event summary

Timeline bucket
May 07, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

3 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 3

CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821745

Z-2136-2024
Recall number
Z-2136-2024
Initiated
May 07, 2024
Classification
Class II
Status
Ongoing
Quantity
135 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging (pouch) leading to a gap or/and weakness of the seal that may compromise
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise

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

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.

Code information

UDI-DI: 10381780515593 Lot numbers: 7320001, 7320004, 720005, 7322926, 322927

Distribution pattern

Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey

device · product 2 of 3

CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749

Z-2137-2024
Recall number
Z-2137-2024
Initiated
May 07, 2024
Classification
Class II
Status
Ongoing
Quantity
106 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging (pouch) leading to a gap or/and weakness of the seal may compromise
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise

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

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

Code information

UDI-DI: 10381780518440 Lot numbers: 7314912, 7320010, 7322933

Distribution pattern

Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey

device · product 3 of 3

CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750

Z-2138-2024
Recall number
Z-2138-2024
Initiated
May 07, 2024
Classification
Class II
Status
Ongoing
Quantity
59 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging (pouch) leading to a gap or/and weakness of the seal may compromise
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise

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

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

Code information

UDI-DI: 10381780518457 Lot Numbers: 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, 7328569

Distribution pattern

Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey