Teleflex Medical Recalls RUSCH LASERTUBE Due to Laser Guard Foil Separation
Teleflex Medical is recalling RUSCH LASERTUBE devices because the laser guard foil partially separated or detached at the edges.
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: The recall is classified as FDA Class II, and the defect involves a laser guard foil separation, which presents a risk of harm (laser exposure) even though specific injury reports are not detailed in the provided text.
Plain-English summary
Teleflex Medical is recalling RUSCH LASERTUBE (Rubber) devices, Order No. 102004-000050, REF 102004, SIZE I.D. mm 5.0. The recall involves 5,995 units distributed nationwide.
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges. This defect is associated with specific lot numbers listed in the recall documentation.
Healthcare providers and consumers should stop using the affected devices and contact Teleflex Medical for further instructions.
The recalled product
- Product
- RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
- Manufacturer
- Teleflex Medical
- Affected units
- 5,995
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 (20)
- Lot Numbers: 14151
- 14161
- 14171
- 14201
- 14211
- 14231
- 14261
- 14271
- 14291
- 14451
- 14461
- 14491
- 14511
- 15041
- 15081
- 15091
- 15101
- 15131
- 15161
- 15201
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Teleflex Medical 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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