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U.S. Department of Health and Human Services

Class 2 Device Recall King systems

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  Class 2 Device Recall King systems see related information
Date Initiated by Firm February 17, 2015
Date Posted April 01, 2015
Recall Status1 Terminated 3 on October 27, 2015
Recall Number Z-1361-2015
Recall Event ID 70610
Product Classification Connector, airway (extension) - Product Code BZA
Product Double Swivel Connector with Suction Port
Connector, Airway (Extension)
King Systems part 7169

Product Usage:
An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.
Code Information Part number 7169 Lot number 1737171
Recalling Firm/
Manufacturer		 King Systems Corp.
15011 Herriman Blvd
Noblesville IN 46060-4253
For Additional Information Contact Wayne Nethercutt
317-776-6823
Manufacturer Reason
for Recall		 Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector without Suction port. If the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Kingsystems sent an Urgent Medical Device Recall letter dated February 17, 2015 to affected customers. The letter identified the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call your King Systems customer service representative at 800.642.5464.
Quantity in Commerce 900 units
Distribution US Nationwide in the states of IL, IN, KY, MI, PA, and TN
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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