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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70719

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

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Event summary

Timeline bucket
February 26, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Civco Medical Instruments 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

CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.

Z-1400-2015
Recall number
Z-1400-2015
Initiated
February 26, 2015
Classification
Class II
Status
Terminated
Quantity
120 pouches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Leaks were detected in the recalled lot which may compromise the sterility of the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Leaks were detected in the recalled lot which may compromise the sterility of the product.

Code information

Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01

Distribution pattern

Distributed to the states of CA, IL, MA, MI, MO, and WI.