Z-2243-2016Class II

Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box

Name: Z-2243-2016 Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box
Creator: Parker Medical
Published: 2016-06-02
License: https://open.fda.gov/license/

Parker Medical / initiated 2016-06-02 / Terminated / root cause: manufacturing process

FDA source

Parker Medical began a recall of Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove... on 2016-06-02. FDA classified it as Class II and gives the reason as "Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2243-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-02
Posted: 2016-07-19
Terminated: 2017-01-31
Recalling firm: Parker Medical
Product: Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were notified on June 2, 2016 that a recall was initiated via telephone. The information communicated identified the affected product, problem and actions to be taken. Customers were instructed to segregate the affected product for immediate pick-up. A Sales Representatives went to each hospital and retrieved all unused product.
Quantity in commerce: 5,500 units
Distribution: US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
Product codes and lots: Model Number: H-PFTVPU-60; H-PFTVPU-65; H-PFTVPU-70; H-PFTVPU-75; H-PFTVPU-80; H-PFTVPU-85; H-PFTVPU-90; H-PFTVVC-60; H-PFTVVC-65; H-PFTVVC-70; H-PFTVVC-75; H-PFTVVC-80; H-PFTVVC-85; H-PFTVVC-90 Lot Numbers: 1512TVC2029I through 1512TVC2029O (I, J, K, L, M, N, O); 1602TVC0226I through 1602TVC2226O (I, J, K, L, M, N, O); 1602TVU0226I through 1602TVU0226O (I, J, K, L, M, N,O); 1512TVU2029I through 1512TVU2029O (I, J, K, L, M, N,O)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2243-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2243-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-19

Product code BTR

K110269Class IIWell Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd. / cleared 2011-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)