The Recall Desk
ModerateFDA (Devices)·Z-1686-2019·Announced 2019-06-05

Teleflex Medical Recalls RUSCH LASERTUBE Due to Partial Foil Separation

Teleflex Medical is recalling 2,325 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached at the edges.

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, but the source text describes a partial separation of the laser guard foil without reporting any injuries, hospitalizations, or deaths. This aligns with a moderate severity rating for a defect that may compromise device function but lacks evidence of significant harm.

Plain-English summary

Teleflex Medical is voluntarily recalling 2,325 units of RUSCH LASERTUBE (Rubber), Order No. 102004-000080, REF 102004, SIZE I.D. mm 8,0. 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 includes specific lot numbers: 14151, 14161, 14201, 14281, 14301, 14321, 14431, 14491, 14511, 15041, 15371, 15441, 16071, 16131, 16191, 16221, 16241, 16271, 16311, 16371, 16391, 16441, 16451, 16481, 16491, 17091, 17121, 17181, 17211, 17241, 17281, 17351, 17381, 17451, 17471, 17491, 18181, 18301, and 18411.

Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to Teleflex Medical according to the firm's instructions.

The recalled product

Product
RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
Manufacturer
Teleflex Medical
Affected units
2,325

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
  • 14201
  • 14281
  • 14301
  • 14321
  • 14431
  • 14491
  • 14511
  • 15041
  • 15371
  • 15441
  • 16071
  • 16131
  • 16191
  • 16221
  • 16241
  • 16271
  • 16311
  • 16371

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 →