Date Initiated by Firm | July 03, 2019 |
Create Date | October 26, 2019 |
Recall Status1 |
Terminated 3 on June 24, 2020 |
Recall Number | Z-0198-2020 |
Recall Event ID |
83386 |
510(K)Number | K103825 |
Product Classification |
Pump, infusion, insulin - Product Code LZG
|
Product | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03 |
Code Information |
UDI: (01)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024 |
Recalling Firm/ Manufacturer |
Valeritas, Incorporated 293 Boston Post Rd W Ste 330 Marlborough MA 01752-4615
|
For Additional Information Contact | 908-927-9920 |
Manufacturer Reason for Recall | There is a potential for "No Needle Demo Units" to contain a needle. |
FDA Determined Cause 2 | Employee error |
Action | On July 3, 2019, Valeritas issued notices to customers via first class U.S. postal service. The removal strategy is to notify active HCP office accounts from the manufacturing start date of effected product (January 2018) who may have No Needle Demo units in their possession. The removal letter instructs HCP offices to dispose of any No Needle Demo product on hand and acknowledgement by signing and returning the removal letter as instructed. |
Quantity in Commerce | 852 devices |
Distribution | Nationwide within U.S. |
Total Product Life Cycle | TPLC 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) Database | 510(K)s with Product Code = LZG
|