FDA Device Recall Z-0002-2014: King Systems Corp.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-2014.

Recall Res Number

Z-0002-2014

Recalling Firm / Manufacturer

King Systems Corp.

FEI Number

1824226

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

0012-12-13

Date Posted

2013-10-01

Date Terminated

2013-11-08

Product Code

CAE

Event Number

66189

Product Quantity

1 case; 5 units

Product Description King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Reason for Recall On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I

Action Details King Systems notified the only one (1) consignee who received the affected product of the problem via a customer complaint. Five (5) of the five (5) affected products were destroyed by consignee.

Distribution Pattern USA Nationwide Distribution in the state of NY

Code Information / Serial Numbers Part Number(s): KLTSD415 Lot Number(s): IV1V3

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Medical Device Recall: Z-0002-2014

Recall Parameters & Description

Related Establishments / Registrations

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