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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77686

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 27, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardinal Health 200, LLC

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

2 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 2

Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Z-2757-2017
Recall number
Z-2757-2017
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1591 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

Code information

Lot 16LFS235, expires November 1, 2021

Distribution pattern

Worldwide Distribution - US (Nationwide including PR) and Canada

device · product 2 of 2

Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Z-2758-2017
Recall number
Z-2758-2017
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
528 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

Code information

Lot 16LUS317, expires November 1, 2021

Distribution pattern

Worldwide Distribution - US (Nationwide including PR) and Canada