Device recall: Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Class II FDA enforcement event 90625. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
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
Trinity Sterile, Inc. started this device recall on 29 Jun 2022. The firm address in the FDA record is in Salisbury, MD. FDA put the recall in Class II. FDA event 90625 has 4 product records. The first FDA enforcement report date is 24 Aug 2022. The record gives the status Terminated, with the termination date 10 May 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of FL, PA.
Recalling firm
Trinity Sterile, Inc., Salisbury, MD.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1548-2022 | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 | 5 cases (125 eaches ) | Class II | Terminated | 24 Aug 2022 |
| Z-1549-2022 | Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF | 1,513 cases (45,390 eaches) | Class II | Terminated | 24 Aug 2022 |
| Z-1550-2022 | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF | 2,512 cases (75,360 eaches ) | Class II | Terminated | 24 Aug 2022 |
| Z-1551-2022 | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF | 4,169 cases (125,070 eaches) | Class II | Terminated | 24 Aug 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 4Median of the firm: 4
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Dec 2024 | Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM4606 | Device | Class II | 5 |
| 23 Feb 2021 | Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter mainte | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1548-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 90625. https://recallregister.com/fda/ii/90625/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of FL, PA.
- What quantity of product is in FDA event 90625?
- The event has 4 product records. The first record gives this quantity:
5 cases (125 eaches )
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.