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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77470

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

Open FDA event record

Event summary

Timeline bucket
June 02, 2017
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Sterilmed 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

St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Z-0213-2018
Recall number
Z-0213-2018
Initiated
June 02, 2017
Classification
Class I
Status
Terminated
Recalling firm
Sterilmed Inc
Quantity
112 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Inadequate seal

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

Inadequate seal due to lack of adhesive glue

Code information

Model No. STJ408309, STJ408310, STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots, known lots: 7344024, 7343120, 7343643, 7343797, 7348305, 7355750, 7348712, 7290257, 7354522, 7354523, 7350001, 7324499, 7343501, 7351203, 7255673, 7273483, 7343603, 7355439, 7355745, 7355754, 7355752, 7282741, 7315539, 7320863, 7343766, 7351038, 7330645, 7345143, 7323722, 7330603, 7342081, 7351724, 7352687, 7355130, 7355131, 7355137, 7377760, 7355135, 7375662, 7404300, 7404301, 7404316, 7404306, 7343395, 7355463, 7355714, 7355622, 7330666, 7355572, 7327999, 7355677, 7308337, 7343686, 7355680, 7251903, 7259400, 7322815, 7342069, 7355574, 7355676, 7355712, 7346336, 7355666, 7355661, 7355618, 7355571, 7354437, 7350573, 7331054, 7300290, 7350792, 7355679, 7355709, 7355713, 7355681, 7355675, 7355573, 7345129, 7343838, 7355678, 7355575, 7355620, 7355711, 7346820, 7355662, 7404299, 7404282, 7404294, 7404290, 7404310, 7404311, 7404318, 7404297, 7404287, 7342672, 7357129, 7241712, 7350942, 7272027, 7316930, 7345592, 7348169, 7388731, 7372138, 7386929, 7387147

Distribution pattern

US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.