Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway

FDA device recall Z-1361-2015 · posted 2015-04-01 · Terminated

Recall details

Recalling firm

King Systems Corp.

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.

Action taken

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

BZA

Quantity affected

900 units

Distribution

US Nationwide in the states of IL, IN, KY, MI, PA, and TN

Date initiated

2015-02-17

Date posted

2015-04-01

Date terminated

2015-10-27

Location

Noblesville, IN