Parker Trach-Vac Endotracheal Tubes Recalled Due to Tube Kinking During Use
Parker Medical is voluntarily recalling Trach-Vac Endotracheal Tubes because they may kink during use, potentially affecting patient ventilation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failure (kinking) that poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Parker Medical is conducting a voluntary field action for Parker Trach-Vac Endotracheal Tubes. These medical devices are used to intubate patients and provide oxygen or anesthetic agents via a ventilator. The recall is due to reports of tube kinking during use.
The affected products are packaged in Tyvek pouches with 10 units per box. Approximately 5,500 units were distributed nationwide in the states of Kentucky, Missouri, Florida, Tennessee, and Texas. The recall covers specific model numbers (H-PFTVPU and H-PFTVVC series) and lot numbers ranging from 1512TVC2029I through 1512TVU2029O.
Healthcare facilities and consumers should stop using the affected endotracheal tubes and contact Parker Medical for instructions on returning the product or obtaining a replacement.
The recalled product
- 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…
- Manufacturer
- Parker Medical
- Affected units
- 5,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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)
Distribution
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