Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
- Company
- Sunmed Holdings, Llc
- Recall Initiated
- September 8, 2022
- Posted
- September 23, 2022
- Terminated
- June 18, 2024
- Recall Number
- Z-1779-2022
- Quantity
- 53,560 units
- Firm Location
- Grand Rapids, MI
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.
Distribution
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Lot / Code Info
UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11
Root Cause
Process control
Action Taken
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 productquality@sun-med.com.