Recall Z-2533-2020
Teleflex Medical Inc · initiated May 29, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
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.
FDA-determined cause: Process design
Action taken
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 recalls@teleflex.com 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 recalls@teleflex.com. 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
Details
- Recall number
- Z-2533-2020
- Initiated
- May 29, 2020
- Terminated
- June 17, 2025
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Quantity
- 6014 devices
- Distribution
- US Nationwide distribution.
- Recalling firm
- Teleflex Medical Inc, Morrisville, NC