Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
FDA Recall Z-1779-2022 · Posted 2022-09-23
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Recalling FirmSunMed Holdings, LLC
Recall StatusTerminated
Product CodeCBT
Date Initiated2022-09-08
Date Terminated2024-06-18
Product Quantity53,560 units
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.
Firm Action
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].
Root Cause
Process control
Distribution Pattern
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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