Medline bronchoscopy packs contain recalled Olympus biopsy valves shedding fragments
Medline is recalling three bronchoscopy convenience kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
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: 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 Medline convenience kits containing Olympus biopsy valves, covering the Bronch Pack (DYKE2096), Non MB Bronchoscopy CCH LH Pack (DYNJT6182) and Pulmonary Bronch Pack (DYNDA2861A). 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 carries UDI-DI 10198459629334, 10198459545283 and 10195327471859, across the lot numbers listed in the FDA enforcement record.
Facilities can identify affected kits by the SKU, UDI and lot numbers above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A
- 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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