Teleflex Medical Recalls RUSCH LASERTUBE Devices Due to Foil Separation
Teleflex Medical is recalling RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges.
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: The recall is classified as FDA Class II, and the hazard involves a medical device defect (foil separation) that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 4,312 units of RUSCH LASERTUBE (Rubber) devices, Order No. 102004-000070, REF 102004, SIZE I.D. mm 7.0. The recall was initiated after the firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
The affected units were distributed nationwide. The recall includes specific lot numbers ranging from 14161 to 18441. The FDA has classified this as a Class II recall.
Healthcare providers and consumers should stop using the affected devices and contact Teleflex Medical for further instructions or a replacement.
The recalled product
- Product
- RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
- Manufacturer
- Teleflex Medical
- Affected units
- 4,312
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: 14161
- 14171
- 14201
- 14211
- 14231
- 14261
- 14301
- 14311
- 14361
- 14431
- 14481
- 14491
- 15041
- 15051
- 15081
- 15091
- 15121
- 15131
- 15161
- 15171
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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