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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78464

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

Open FDA event record

Event summary

Timeline bucket
October 23, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medline Industries 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

Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.

Z-0162-2018
Recall number
Z-0162-2018
Initiated
October 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
8,000 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

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

Possible open seal on top portion of the package. Could cause breach of sterility.

Code information

Model No. MSG1285, Lot No. 701893369485

Distribution pattern

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.

Field note

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