SunMed Pulset Syringes Recalled Due to Non-Sterile Spare Needles
SunMed Holdings is recalling Pulset 3cc syringes with non-sterile spare needles that could cause skin infection or sepsis if used. The recall affects 53,560 units distributed across ten US states.
What this means for you
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: FDA Class II medical device recall for non-sterile needles with potential for serious infection or sepsis. No reported illnesses or injuries in the source text. Per the severity rubric, theoretical hazards without reported harm in Class II recalls score as High (3).
Plain-English summary
SunMed Holdings, LLC is recalling Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH (REF Number 3373-91) due to a lack of sterility in the spare needle contained within the kits.
The non-sterile, unused needle poses a potential risk of skin infection or sepsis if a patient is exposed to it during use. The recall affects 53,560 units that were distributed domestically to Alabama, Florida, Georgia, Illinois, Louisiana, Missouri, New Jersey, New York, Tennessee, and Texas.
Healthcare providers and patients who have received or are using these syringes should stop using them immediately. Those with affected units should contact SunMed Holdings or their medical supplier for guidance on replacement or disposal. Lot numbers affected are 010822N23, 052521N54, 081821N05, and 101221N11.
The recalled product
- Product
- Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
- Manufacturer
- SunMed Holdings, LLC
- Hazard
- sterility-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00709078004483 (each label)
- 10709078004480 (box label) Lots 010822N23
- 052521N54
- 081821N05
- 101221N11
Distribution
Distributed in 10 states:
- AL
- FL
- GA
- IL
- LA
- MO
- NJ
- NY
- TN
- TX
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