Full Kit Pulset 3cc Syringe recall: Sterility Concern
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Why was Full Kit Pulset 3cc Syringe 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11
- Product
- Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
- Recalling firm
- SunMed Holdings, LLC
- Quantity
- 53,560 units
- Distribution
- Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
- Recall date
- October 5, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)