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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard Closed Suction System for Adults

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  Class 2 Device Recall Halyard Closed Suction System for Adults see related information
Date Initiated by Firm October 06, 2017
Date Posted November 18, 2017
Recall Status1 Terminated 3 on September 01, 2020
Recall Number Z-0119-2018
Recall Event ID 78391
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
Product Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Code Information Product Code 22106 with Lots AB6011U20, AB6123U07 AB6123U01, AB3207U04, AB6284U17; Product Code 221036 with Lot AB6263U11; Product Code 22108147 with Lots AB6011U15, AB6067U17, AB6256U13
Recalling Firm/
Manufacturer		 Halyard Health, Inc
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Thomas Kozma, PhD
470-448-5681
Manufacturer Reason
for Recall		 Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were notified via FedEx on 10/06/2017. Instructions included to evaluate and quarantine any affected product in current inventory. For their direct distributors, instructions were to complete and return the response form and also coordinate the return of any affected product. If further distributed, those end users and customers were instructed to destroy any affected product.
Quantity in Commerce 52,660 kits (2,633 cases) with 631,920 saline vials
Distribution Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
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.
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