Z-1851-2014Class II

RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A...

Name: Z-1851-2014 RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A...
Creator: Teleflex Medical
Published: 2014-05-23
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-05-23 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's... on 2014-05-23. FDA classified it as Class II and gives the reason as "Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1851-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-23
Posted: 2014-06-23
Terminated: 2016-01-13
Recalling firm: Teleflex Medical
Product: RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Teleflex Medical sent a Urgent Medical Device Recall Notification dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above from the lot numbers listed on the attachment. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 1658 ea
Distribution: Nationwide Distribution and the country of Colombia.
Product codes and lots: Product Code: 102004040, Lot #13371, 13381, 13291, 13281, 13251 & 13231; Product Code: 102004050, Lot #13461, 13441, 13401, 13431, 13421, 13381, 13371, 1329, 13301, 13311, 13361, 13261, 13231, 13251 & 13241; Product Code: 102004060, Lot #13441, 13451, 13431, 13411, 13381, 13361, 13311, 13301, 13281, 13271, 13261, 13241 & 13231; Product Code: 102004070, Lot #13441, 13421, 13381, 13351, 13291, 13311, 13271 & 13261; Product Code: 102004070, Lot #13251 & 13241; and Product Code: 102004080, Lot #13371, 13301 & 13251.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1851-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1851-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)