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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90625

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

Open FDA event record

Event summary

Timeline bucket
June 29, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Trinity Sterile, 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

4 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 4

Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708

Z-1548-2022
Recall number
Z-1548-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Recalling firm
Trinity Sterile, Inc.
Quantity
5 cases (125 eaches )

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Code information

UDI-DI Number: 50649111317590 Case 10649111317590 Kit Lot Numbers: 600001 600002

Distribution pattern

US Nationwide distribution in the states of FL, PA.

device · product 2 of 4

Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF

Z-1549-2022
Recall number
Z-1549-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Recalling firm
Trinity Sterile, Inc.
Quantity
1,513 cases (45,390 eaches)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Code information

UDI-DI: 10850007185760 Case 00850007185763 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600006 600007 600008

Distribution pattern

US Nationwide distribution in the states of FL, PA.

device · product 3 of 4

Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

Z-1550-2022
Recall number
Z-1550-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Recalling firm
Trinity Sterile, Inc.
Quantity
2,512 cases (75,360 eaches )

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Code information

UDI-DI: 10850007185746 Case 00850007185749 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012

Distribution pattern

US Nationwide distribution in the states of FL, PA.

device · product 4 of 4

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Z-1551-2022
Recall number
Z-1551-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Recalling firm
Trinity Sterile, Inc.
Quantity
4,169 cases (125,070 eaches)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Code information

UDI-DI: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019

Distribution pattern

US Nationwide distribution in the states of FL, PA.