CLASS II Device recall · Reported 24 Aug 2022 · FDA Enforcement Report
Sklar Instruments IV Cath Dressing Tray Cs/25 Re recalled
Trinity Sterile is recalling Sklar Instruments IV Cath Dressing Tray Cs/25 Re, distributed nationwide in the US. The recall was initiated on 29 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1548-2022
- FDA event ID
- 90625
- Recalling firm
- Trinity Sterile, Salisbury, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2022
- FDA classified
- 18 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 29 Jun 2022 | Recall initiated by company | |
| 18 Aug 2022 | Classified by FDA | +50 days |
| 24 Aug 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Where it was distributed
US Nationwide distribution in the states of FL, PA.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
UDI-DI Number: 50649111317590 Case 10649111317590 Kit Lot Numbers: 600001 600002
Where was it sold?
US Nationwide distribution in the states of FL, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 90625| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 recalled | Trinity Sterile | Labeling Errors | Nationwide | |
| CLASS II | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 recalled | Trinity Sterile | Labeling Errors | Nationwide | |
| CLASS II | Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 recalled | Trinity Sterile | Labeling Errors | Nationwide |
More recalls from Trinity Sterile
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tacy Medical, Inc Dressing Change Tray CS/20 recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Dressing Change Kit recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Dressing Change Kit recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | IMed Products Dressing Change Kit with ChloraPrep & HaloGUARD recalled | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled | Trinity Sterile | Sterility | Nationwide |
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| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |