FDA Device

KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Hazard

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

What You Should Do

Remedy

Halyard sent a Product Advisory Notice on July 29, 2015, via FEDEX with a second letter dated August 12, 2015, being issued via FEDEX. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to report any occurrence of a valve leak to Halyard Customer Service at 1-844-425-9273, option 1, option 3.

Affected by this recall?

Get a free legal consultation about this recall.

Talk to a Lawyer →

Affiliate link

Products

KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135)
Brand
Halyard Health, Inc
UPC
Product Code 2155 - M5166T402, M5166T622, M5166T631; Product Code 2205 - M5079T606, M5086T603, M5089T612, M5089T632, M5110T611, M5110T626, M5166T642; Product Code 8169 - M5103T608; Product Code 8248 - M5082T632; Product Code 22015 - M5082T603, M5089T609, M5096T607; Product Code 22025 - M5082T627, M5096T603; Product Code 220125 M5082T617, M5096T608; Product Code 220135 - M5054T619, M5079T604, M5082T620, M5089T614, M5096T622

Units Affected

19,250 cases

Related Recalls

FDA DEVICE

The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.

 FDA DEVICE

HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.

 FDA DEVICE

Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.

 FDA DEVICE

CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen

 FDA DEVICE

BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System. SurePath Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.