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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75737

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

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Event summary

Timeline bucket
October 24, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ansell Healthcare Products 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

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

Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285

Z-0893-2017
Recall number
Z-0893-2017
Initiated
October 24, 2016
Classification
Class II
Status
Terminated
Quantity
15 Cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.

Code information

Lot 1607018105

Distribution pattern

US Distribution to the states of : PA, FL, NJ, IL and MA.