The Recall Desk
HighFDA (Devices)·Z-1684-2019·Announced 2019-06-05

Teleflex Medical Recalls RUSCH LASERTUBE Due to Laser Guard Foil Separation

Teleflex Medical is recalling 4,312 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached 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 defect involves a laser guard foil separation, which poses a risk of harm (laser exposure) even though specific injury reports are not detailed in the source text.

Plain-English summary

Teleflex Medical is recalling 4,312 units of RUSCH LASERTUBE (Rubber), Order No. 102004-000060, REF 102004, SIZE I.D. mm 6.0. 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 products were distributed nationwide. The recall covers specific lot numbers, including 15411, 15421, 15431, and many others listed in the official recall notice. The agency has classified this as a Class II recall.

Healthcare providers and consumers should stop using the affected RUSCH LASERTUBE products and contact Teleflex Medical for instructions on return or replacement. Users should verify their product lot numbers against the list provided in the official recall documentation to determine if their units are affected.

The recalled product

Product
RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
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: 15411
  • 15421
  • 15431
  • 15441
  • 15451
  • 15461
  • 15471
  • 15501
  • 16031
  • 16061
  • 16081
  • 16091
  • 16101
  • 16131
  • 16151
  • 16161
  • 16171
  • 16181
  • 16191
  • 16201

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.

See all 5 products in this recall →