Z-2533-2020Class II

RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0...

Name: Z-2533-2020 RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0...
Creator: Teleflex Medical Inc
Published: 2020-05-29
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2020-05-29 / Terminated / root cause: manufacturing process

FDA source

TELEFLEX MEDICAL INC began a recall of RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code... on 2020-05-29. FDA classified it as Class II and gives the reason as "Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture". 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-2533-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-29
Posted: 2020-07-10
Terminated: 2025-06-17
Recalling firm: Teleflex Medical
Product: RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 m to 10.6 m.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm initiated the recall by letter on 05/29/2020. The customer letter requested the following actions: "1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected] or hand it to your sales representative. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products." The distributor letter requested the following actions: "1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990. 4. To return recalled products to Teleflex Medical, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. 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. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have c
Quantity in commerce: 6014 devices
Distribution: US Nationwide distribution.
Product codes and lots: a) I.D. mm 4,0, Product Code 102004-000040, Lot numbers: 19491, 19501, 19511, 20021, 20041, 20091 b) I.D. mm 5,0, Product Code 102004-000050, Lot numbers: 19471, 19501, 19511, 20021, 20031, 20041, 20051, 20061, 20071, 20101, 20111, 20121 c) I.D. mm 6,0, Product Code 102004-000060, Lot numbers: 19481, 19491, 19501, 20081, 20091, 20101, 20111, 20121, 20131 d) I.D. mm 7,0, Product Code 102004-000070, Lot numbers: 19451, 19461, 19471, 19501, 20021, 20031, 20051, 20091, 20111 e) I.D. mm 8,0, Product Code 102004-000080, Lot numbers: 19451, 19481, 19501, 19511, 20041, 20111, 20121

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2533-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2533-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07

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)