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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81524

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

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Event summary

Timeline bucket
October 12, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Atrium Medical Corporation

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

Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

Z-0560-2019
Recall number
Z-0560-2019
Initiated
October 12, 2018
Classification
Class II
Status
Terminated
Quantity
2930 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
contamination of the device, the microorganisms
Sterility assurance reason.sterility_assurance · v1.0.0
seal defect found in certain sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

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Inspect official wording and provenance

Reason for recall

This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.

Code information

ME221275

Distribution pattern

Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.