Medical dressing tray mislabeled as latex-free but contains natural rubber latex
Trinity Sterile's IV catheter dressing trays are mislabeled as latex-free despite containing natural rubber latex in component 94-7002, risking allergic reactions in latex-sensitive users.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Allergen mislabeling on latex, a common allergen, without reported illnesses or injuries meets the rubric criterion for High (3). The source contains no adverse event reports, making this a theoretical risk scenario.
Plain-English summary
Trinity Sterile, Inc. has recalled Sklar Instruments IV Cath Dressing Tray (Re-Order Number 96-1708) distributed in Florida and Pennsylvania. The product is mislabeled as latex-free; however, component 94-7002 (Non-Adherent Dressing) contains natural rubber latex. Affected lots are 600001 and 600002.
Individuals with latex allergies face a potential allergic reaction risk if they use this product without knowing about the latex content. The FDA classified this as a Class II medical device recall.
If you have received this product, do not use it if you have a known latex allergy. Contact Trinity Sterile, Inc. or consult a healthcare provider if exposure has occurred.
The recalled product
- Product
- Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
- Manufacturer
- Trinity Sterile, Inc.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Trinity Sterile, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Trinity Sterile, Inc.
See all →- HighDressing Change Tray Recalled Due to Potential Package Sterility Compromise
FDA (Devices) · 2025-01-29
- HighDressing Change Kits Recalled for Potential Package Sterility Compromise
FDA (Devices) · 2025-01-29
- HighWolf-Pak Dressing Change Kits Recalled Due to Package Defects
FDA (Devices) · 2025-01-29
- HighDressing Change Kit Recalled Due to Package Integrity Concern
FDA (Devices) · 2025-01-29
- HighDressing change kits recalled due to packaging defect compromising sterility
FDA (Devices) · 2025-01-29
Same hazard · allergen latex
See all →- HighHalyard DAVINCI TRUCUSTOM Foley Catheter Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Error
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateWelch Allyn DuraShock Aneroid Gauge Sets Reusable Blood Pressure Cuff Recall
FDA (Devices) · 2025-04-23
- HighWelch Allyn Reusable Blood Pressure Cuff Kits Recalled for Undeclared Rubber
FDA (Devices) · 2025-04-23
Similar recalls
- SevereMedline Laceration Trays Recalled Due to Sterility Defect
FDA (Devices) · 2024-03-06
- SevereDressing change tray recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- HighBardex Foley catheter trays recalled over inserts describing the wrong material
FDA (Devices) · 2025-09-24
- HighDressing Change Tray Recalled Due to Potential Package Sterility Compromise
FDA (Devices) · 2025-01-29
- HighLubri-Sil Foley trays recalled over inserts describing the wrong catheter material
FDA (Devices) · 2025-09-24
- HighFoley catheter trays recalled because inserts describe the wrong catheter material
FDA (Devices) · 2025-09-24