Medline Suction Liners Recalled for Potential Loss of Suction
Medline is recalling specific lots of semi-rigid suction liners due to potential loss of suction during clinical use. The recall affects convenience kits distributed to healthcare facilities in the US, Canada, and Panama.
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: FDA Class II medical device with reported adverse events. The functional defect (loss or low suction) in a clinical suction device used during endoscopy procedures represents a significant risk of harm, justifying High severity despite no specific hospitalization reports being documented.
Plain-English summary
Medline Industries, LP is recalling specific lots of 1500 cc semi-rigid suction liners included in three convenience kit products: ENDO BRONCH PACK (Pack Number DYKE1355), ENDO BASIC KIT (Pack Number DYKE1356), and ENDOSCOPY KIT (Pack Number DYKE1771C). The liners manufactured between September 2023 and November 2023 are subject to recall due to the potential loss of suction or low suction during intermittent suction use.
The recall involves 6,257 units with specific lot numbers: DYKE1355 lots 23LBB043, 24BBJ327, and 24CBS751; DYKE1356 lots 23LBD062, 24ABA646, 24BBJ328, 24CBG449, 24DBE106, and 24EBG238; and DYKE1771C lot 24ABX292. The affected products have been distributed nationwide in the United States and internationally in Canada and Panama.
Healthcare facilities and providers using these products should verify whether they have received any of the affected lots. If any affected kits are in use or in inventory, discontinue use immediately and contact Medline Industries, LP for instructions regarding replacement or return of the recalled products.
The recalled product
- Product
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- suction-failure
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 (16)
- a) DYKE1355: UDI/DI case 40889942274193
- UDI/DI each 10889942274192
- Lot Numbers: 23LBB043
- 24BBJ327
- 24CBS751
- b) DYKE1356: UDI/DI case 40889942274186
- UDI/DI each 10889942274185
- Lot Numbers: 23LBD062
- 24ABA646
- 24BBJ328
- 24CBG449
- 24DBE106
- 24EBG238
- c) DYKE1771C: UDI/DI case 40195327331994
- UDI/DI each 10195327331993
- Lot Numbers: 24ABX292
Distribution
Distributed nationwide across the United States.
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