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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard TurboCleaning Closed Suction System

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 Class 2 Device Recall Halyard TurboCleaning Closed Suction Systemsee related information
Date Initiated by FirmOctober 06, 2017
Date PostedNovember 18, 2017
Recall Status1 Terminated 3 on September 01, 2020
Recall NumberZ-0118-2018
Recall Event ID 78391
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
ProductHalyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case.
Code Information Product Code 2276, Lots AB6018U03, AB6137U12, AB6305U17.
Recalling Firm/
Manufacturer		 Halyard Health, Inc
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information ContactThomas 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
ActionCustomers 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 Commerce52,660 kits (2,633 cases) with 631,920 saline vials
DistributionDistributed 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 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.
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