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Terminated

RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0

FDA Recall Z-1683-2019 · Posted None

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTR
Date Initiated2019-04-01
Date Terminated2025-06-03
Product Quantity5995 units

Reason for Recall

The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

Firm Action

The firm initiated the recall by letter on 04/01/2019. The letter stated reason for the recall and requested the return of the recalled units. Distributors were directed to collect the recalled units from their customers, consolidate them, and complete and return the acknowledgement form. The recalled units will be returned.

Root Cause

Process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935842RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYERusch, Inc. · 1995-05-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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