Device recall: Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Class II FDA enforcement event 90834. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.
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
SunMed Holdings, LLC started this device recall on 8 Sep 2022. The firm address in the FDA record is in Grand Rapids, MI. FDA put the recall in Class II. FDA event 90834 has 1 product record. The first FDA enforcement report date is 5 Oct 2022. The record gives the status Terminated, with the termination date 18 Jun 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.
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Recalling firm
SunMed Holdings, LLC, Grand Rapids, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1779-2022 | Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 | 53,560 units | Class II | Terminated | 5 Oct 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
- 1Median of the firm: 2
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Dec 2025 | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Vers | Device | Class I | 4 |
| 15 May 2025 | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-234 | Device | Class I | 1 |
| 1 May 2025 | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F | Device | Class I | 1 |
| 11 Oct 2023 | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include | Device | Class II | 9 |
| 22 Dec 2022 | Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-1779-2022The 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 90834. https://recallregister.com/fda/ii/90834/. 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:
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
- What quantity of product is in FDA event 90834?
- The FDA record gives this quantity:
53,560 units
- 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.