CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report
Parker Trach-Vac Endotracheal Tubes recalled by Parker Medical
Parker Medical is recalling Parker Trach-Vac Endotracheal Tubes, distributed nationwide in the US. The recall was initiated on 2 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2243-2016
- FDA event ID
- 74547
- Recalling firm
- Parker Medical, Highlands Ranch, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jun 2016
- FDA classified
- 19 Jul 2016
- Reported
- 27 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 2 Jun 2016 | Recall initiated by company | |
| 19 Jul 2016 | Classified by FDA | +47 days |
| 27 Jul 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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)
Where was it sold?
US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Parker Medical
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|---|---|---|---|---|---|
| Device | CLASS II | Parker Left Double Lumen Endobronchial Tube recalled by Parker Medical | Parker Medical | Other | Nationwide |
Other CPAP & Ventilators recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |