Medline thoracic robot kits contain recalled Olympus biopsy valves
Medline is recalling Thoracic Robots kits, model DYNJ908777B, because they contain recalled Olympus biopsy valves where rubber fragments may detach from the valve slit.
What this means for you
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: fragments may lodge in a patient's airway and require removal, and no injuries are stated in the source.
Plain-English summary
Medline Industries, LP is recalling Thoracic Robots kits, model DYNJ908777B. About 14,379 kits were distributed across thirteen US states. The FDA has classified this recall as Class II.
The kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences of fragment detachment include a foreign body in the patient's tracheobronchial tree, which may require intervention for removal, along with inflammatory response, hypoxia and prolongation of the procedure.
Affected product is identified by the model number above.
Facilities can identify affected kits by the model number, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- THORACIC ROBOTS, DYNJ908777B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Endoscopy
- Affected units
- 14,379
Distribution
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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