Z-1682-2019Class II

RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0

Name: Z-1682-2019 RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
Creator: Teleflex Medical
Published: 2019-04-01
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-04-01 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0 on 2019-04-01. FDA classified it as Class II and gives the reason as "The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1682-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-01
Posted: 2019-05-29
Terminated: 2025-06-03
Recalling firm: Teleflex Medical
Product: RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 1787 units
Distribution: Nationwide
Product codes and lots: Lot Numbers: 14151, 14161, 14171, 14211, 14231, 14271, 14281, 14321, 14441, 14461, 14501, 14511, 15031, 15051, 15091, 15101, 15251, 15271, 15411, 16051, 16071, 16101, 16161, 16171, 16201, 16231, 16271, 16291, 16301, 16311, 16361, 16381, 16401, 16421, 16431, 16451, 16481, 16501, 16511, 17021, 17031, 17051, 17071, 17091, 17111, 17121, 17161, 17181, 17191, 17201, 17251, 17261, 17271, 17281, 17351, 17371, 17461, 18021, 18031, 18061, 18101, 18121, 18161, 18201, 18351, 18361, 18401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1682-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1682-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29
Z-1683-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29
Z-1684-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29
Z-1685-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29
Z-1686-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29

Product code BTR

K935842Class IIRusch Lasertubus/rusch Laser Resistant Cuffed with Murphy EyeRusch, Inc. / cleared 1995-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)