Pulset recallZ-1779-2022 · SunMed Holdings, LLC · initiated Sep 8, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SunMed Holdings, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
On September 8, 2022, the firm sent Urgent Medical Device Product Removal letters via email to affected customers. Customers were instructed to either return or destroy and discard affected product. If customers have further distributed the affected device, they should forward the notification to the receiving facility. Sun Med will provide new replacement product. If you have any questions regarding this field action, please call SunMed at 1-800-433-2797, or e-mail at [email protected].
Recall details
- Recall number
- Z-1779-2022
- Status
- Terminated
- Initiated by the company
- Sep 8, 2022
- Posted by the FDA
- Sep 23, 2022
- Recalling firm
- SunMed Holdings, LLC
- Quantity
- 53,560 units
- Product code
- CBT
- FDA submissions
- K944941
- Distribution
- Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Product description
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Code information (models, lots, serial numbers)
UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pulset 3373-91Westmed, Inc. · Arterial Blood Sampling Kit1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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