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U.S. Department of Health and Human Services

Class 2 Device Recall Pulset 3cc Syringe

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 Class 2 Device Recall Pulset 3cc Syringesee related information
Date Initiated by FirmSeptember 08, 2022
Date PostedSeptember 23, 2022
Recall Status1 Terminated 3 on June 18, 2024
Recall NumberZ-1779-2022
Recall Event ID 90834
510(K)NumberK944941 
Product Classification Arterial blood sampling kit - Product Code CBT
ProductFull Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Code Information UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11
Recalling Firm/
Manufacturer		 SunMed Holdings, LLC
2710 Northridge Dr Nw Ste A
Grand Rapids MI 49544-9112
For Additional Information ContactRob Yamashita
616-259-8400
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce53,560 units
DistributionDomestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CBT
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