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U.S. Department of Health and Human Services

Class 2 Device Recall RUSCH LASERTUBE

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 Class 2 Device Recall RUSCH LASERTUBEsee related information
Date Initiated by FirmApril 01, 2019
Create DateMay 29, 2019
Recall Status1 Terminated 3 on June 03, 2025
Recall NumberZ-1686-2019
Recall Event ID 82552
510(K)NumberK935842 
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
ProductRUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
Code Information 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, 18411  
FEI Number 3005747797
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contactcustomer service
866-396-2111
Manufacturer Reason
for Recall		The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce2325 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BTR
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