King Systems Recalls
15 recalls on record · November 28, 2012 to April 8, 2015 · Medical Devices
Recalls by year
12
13
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
April 8, 2015Medical DevicesFDA
King Systems Corp. recalls Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An a
Hazard: 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.
January 22, 2014Medical DevicesFDA
King Systems Corp. recalls King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identifica
Hazard: 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.
October 9, 2013Medical DevicesFDA
King Systems Corp. recalls Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intend
Hazard: King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.
October 9, 2013Medical DevicesFDA
King Systems Corp. recalls King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of
Hazard: 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
September 25, 2013Medical DevicesFDA
King Systems Corp. recalls King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controll
Hazard: Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible K
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible K
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ P
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ P
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Pat
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Siz
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Siz
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Siz
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
November 28, 2012Medical DevicesFDA
King Systems Corp. recalls KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size
Hazard: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO