Teleflex Recalls RUSCH LASERTUBE Devices Due to Laser Guard Foil Separation
Teleflex is voluntarily recalling 6,014 RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges when exposed to moisture.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a voluntary recall based on reports of partial separation without explicit mention of reported injuries, hospitalizations, or deaths. This aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor defects where harm has not yet been reported.
Plain-English summary
Teleflex Medical Inc. is voluntarily recalling 6,014 units of RUSCH LASERTUBE (Rubber) devices, product code RES 102004. The affected devices are available in five internal diameter sizes (4.0 mm, 5.0 mm, 6.0 mm, 7.0 mm, and 8.0 mm) and were distributed nationwide in the United States.
The recall is being initiated due to reports indicating that the laser guard foil on these devices may partially separate or slightly detach at the edges in the presence of moisture. These tubes are designed for tracheal intubation during laser surgery in the laryngeal area and are resistant to specific laser types, including Ar+ laser, ND/YAG laser, and CO2 lasers.
Healthcare facilities and users should stop using the affected devices and contact Teleflex Medical Inc. for further instructions on the recall process. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage:
- Manufacturer
- TELEFLEX MEDICAL INC
- Affected units
- 6,014
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)
- a) I.D. mm 4
- 0
- Product Code 102004-000040
- Lot numbers: 19491
- 19501
- 19511
- 20021
- 20041
- 20091 b) I.D. mm 5
- Product Code 102004-000050
- Lot numbers: 19471
- 20031
- 20051
- 20061
- 20071
- 20101
- 20111
- 20121 c) I.D. mm 6
- Product Code 102004-000060
- Lot numbers: 19481
Distribution
Distributed nationwide across the United States.
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