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U.S. Department of Health and Human Services

Class 1 Device Recall IV Flush

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  Class 1 Device Recall IV Flush see related information
Date Initiated by Firm October 04, 2016
Date Posted January 03, 2017
Recall Status1 Terminated 3 on August 16, 2017
Recall Number Z-0926-2017
Recall Event ID 75348
510(K)Number K150143  
Product Classification Saline, vascular access flush - Product Code NGT
Product Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP

Product usage: Saline flush
Code Information Item Number 1203: 1511075, 1604273; Item Number 1205: 1511001, 1602028, 1603060; Item Number 1210: 1509282, 1511328, 1511329, 1512048, 1512053, 1512072, 1601355, 1602048, 1602137, 1602178, 1603029, 1605387, 1606076; Item Number 1210-BP: 1604431,1604432, 1604433, 1606254, 1607018, 1607195, 1607418 (All lots within expiry)
Recalling Firm/
Manufacturer		 Nurse Assist, Inc
4409 Haltom Rd
Haltom City TX 76117-1207
For Additional Information Contact
817-231-1300
Manufacturer Reason
for Recall		 Potential contamination with B. cepacia.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Nurse Assist, Inc. sent an Urgent Medical Device Recall letter dated October 4, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use, a Returned Goods Authorization would be provided for return of the affected product. If product was further distributed consignees were instructed to make every effort to retrieve any of the unused product. For questions consignees should call 800-649-6800 or email productremovalinfo@nurseassist.com. For questions regarding this recall call 817-231-1300.
Quantity in Commerce 386,175 syringes
Distribution Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.
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 = NGT and Original Applicant = NURSE ASSIST, INC.
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