Exact FDA event identifier

Event 61832

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

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Event summary

Timeline bucket: May 04, 2012
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Argon Medical Devices, Inc

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

Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.

Z-1946-2012

Recall number: Z-1946-2012
Initiated: May 04, 2012
Classification: Class II
Status: Terminated
Recalling firm: Argon Medical Devices, Inc
Quantity: 10 pieces

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

pouch seal. The pouch issue may compromise

Sterility assurance reason.sterility_assurance · v1.0.0

seal. The pouch issue may compromise the sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.

Code information

Lot Number 204889, Expiration Date March 2017

Distribution pattern

Distributed only in Missouri.