Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2533-2020·Announced 2020-07-15

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.

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 2/5 (Moderate).

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…
Manufacturer: TELEFLEX MEDICAL INC
Category: Medical Device — Airway Management
Hazard: component-separation
moisture-exposure
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.

Same manufacturer · TELEFLEX MEDICAL INC

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Same hazard · component separation