Recall archive / FDA device enforcement
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF — FDA record Z-1551-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
- Reason
- 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
- Classification
- Class II
- Recalling firm
- Trinity Sterile, Inc.
- Quantity
- 4,169 cases (125,070 eaches)
- Agency-reported status
- Terminated
- Source record identifier
- Z-1551-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of FL, PA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 24, 2022
- Recall initiation date
- Jun 29, 2022
- Center classification date
- Aug 18, 2022
- Termination date
- May 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.