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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson

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  Class 2 Device Recall McKesson see related information
Date Initiated by Firm September 04, 2018
Create Date October 16, 2018
Recall Status1 Completed
Recall Number Z-0119-2019
Recall Event ID 81113
510(K)Number K993017  
Product Classification Syringe, piston - Product Code FMF
Product McKesson Insulin Syringe 0.3mL 31GX5/16
Item Numbers: 102-SN310C31516P

Product Usage:
Indication of Use: Injection of U-100 insulin only.
Code Information Lot Code: KSH0603
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
9954 Mayland Dr
Richmond VA 23233-1464
For Additional Information Contact SAME
815-385-0100
Manufacturer Reason
for Recall		 Small hole at the end of the syringe is impeding suction of liquid.
FDA Determined
Cause 2		 Equipment maintenance
Action Cypress Medical Products LLC notified the distributor, McKesson Medical-Surgical, on 9/4/18. McKesson Medical-Surgical is responsible for communications to the distribution centers and end users. Any material on hand at end user facilities will be returned to the McKesson DC. Accounts requested to cease distribution and quarantine product for return. A response form included with letter to be completed and returned.
Quantity in Commerce 400 cases
Distribution US Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = SHIN CHANG MEDICAL CO., LTD.
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