Medline laryngoscopy bronchoscopy kits contain Olympus valves shedding rubber fragments
Medline is recalling four bronchoscopy and laryngoscopy kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
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 kits containing Olympus biopsy valves, covering Bronchoscopy kits (DYNJ900898I, DYNJ901922G), the Flexible Bronchoscopy Kit (DYKM1417I, DYKM1417J), the Laryngoscopy/Bronchoscopy Pack (DYNJ58146A) and the Rigid Kit (DYNDA2138A). 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.
Each kit carries its own UDI-DI and lot numbers, listed in the FDA enforcement record.
Facilities can identify affected kits by the SKU, UDI and lot numbers, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Endoscopy
- Hazard
- fragment-detachment
- foreign-body-risk
- airway-risk
Distribution
Distributed nationwide across the United States.
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