Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per… recallZ-2243-2016 · Parker Medical · initiated Jun 2, 2016
Class II Terminated All recalls posted in July 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Parker Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2243-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 2, 2016
- Posted by the FDA
- Jul 19, 2016
- Recalling firm
- Parker Medical
- Quantity
- 5,500 units
- Product code
- BTR
- FDA submissions
- K110269
- Distribution
- US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
Product description
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.
Code information (models, lots, serial numbers)
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)
Other devices under the same FDA submission
6 devices cleared under K110269 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medline DYNJ18875Medline Industries, Inc. · Tube, tracheal (w/wo connector)1 recall6 reports
- Medline DYNJ18870Medline Industries, Inc. · Tube, tracheal (w/wo connector)1 recall4 reports
- Medline DYNJ18880Medline Industries, Inc. · Tube, tracheal (w/wo connector)1 recall2 reports
- Medline DYNJ18860Medline Industries, Inc. · Tube, tracheal (w/wo connector)1 recall1 report
- Medline DYNJ18865Medline Industries, Inc. · Tube, tracheal (w/wo connector)1 recall0 reports
- Medline DYNJ18885Medline Industries, Inc. · Tube, tracheal (w/wo connector)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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