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U.S. Department of Health and Human Services

Class 2 Device Recall 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

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 Class 2 Device Recall 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826see related information
Date Initiated by FirmNovember 05, 2018
Create DateDecember 21, 2018
Recall Status1 Terminated 3 on August 14, 2020
Recall NumberZ-0656-2019
Recall Event ID 81607
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
Product8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Code Information Lot Number 1816211264
Recalling Firm/
Manufacturer		 COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
Manufacturer Reason
for Recall		The product was released into commercial distribution while subject to importation refusal.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent Medical Device Recall letters dated 11/5/18 were sent to customers.
Quantity in Commerce32,071 units
DistributionThe products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
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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