CLASS II Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Full Kit Pulset 3cc SyringeSafety Tip 25u BH recalled by SunMed Holdings
SunMed Holdings is recalling Full Kit Pulset 3cc SyringeSafety Tip 25u BH, distributed in 10 states. The recall was initiated on 8 Sep 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-1779-2022
- FDA event ID
- 90834
- Recalling firm
- SunMed Holdings, Grand Rapids, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2022
- FDA classified
- 23 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 8 Sep 2022 | Recall initiated by company | |
| 23 Sep 2022 | Classified by FDA | +15 days |
| 5 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Where it was distributed
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
AlabamaFloridaGeorgiaIllinoisLouisianaMissouriNew JerseyNew YorkTennesseeTexas
Questions about this recall
Is Full Kit Pulset 3cc SyringeSafety Tip 25u BH recalled?
Yes. SunMed Holdings recalled Full Kit Pulset 3cc SyringeSafety Tip 25u BH on 8 Sep 2022. The recall is Class II and its status is Terminated. Recall number Z-1779-2022.
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11
Where was it sold?
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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