Medline Tracheostomy Convenience Kits Recalled Due to Defective Component
Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.
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: This is an FDA Class II recall of medical devices for respiratory care containing a component that was recalled by Stryker. The devices are inherent risk-of-harm products, though no illnesses or injuries have been reported to date.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits for tracheostomy care under the product names TRACH TOTE (REF DYNJ85691) and TRACHEOSTOMY (REF DYNJ902123J). The kits were manufactured using components from SafeAir Smoke Evacuation Pencil, which were subsequently recalled by Stryker.
The recall affects 88 units that were distributed nationwide in the United States. Specific lot numbers have been identified and are available through the FDA recall announcement.
Consumers should stop using the recalled kits immediately. Affected products can be identified by their reference numbers and lot codes. For questions or to arrange returns, consumers should contact Medline Industries or the FDA.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-defect
- component-defect
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 (9)
- 1) REF DYNJ85691
- UDI/DI 10195327534141 (each) 40195327534142 (case)
- Lot Numbers: 24ABR853
- 2) REF DYNJ902123J
- UDI/DI 10195327497453 (each) 40195327497454 (case)
- Lot Numbers: 23JDB498
- 24DDA877
- 24CDB678
- 24BDB737
Distribution
Distributed nationwide across the United States.
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