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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.
Recall Number Z-0709-2014
Classification Class II
Code Info Lot Number(s): I15LB
Product Distributed Qty 108 cases( 540 products)
Reason For Recall KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gastric suction tube; the KLTD214 airway does not include a lumen for a gastric suction tube.

Event Detail

Event Id 66869
Product Type Devices
Status Ongoing
Recalling Firm King Systems Corp.
City Noblesville
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 0013-12-10
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Distributed in the states of CA, KS, MS, NY, and TX.