Recall Z-2533-2020 ยท BTR Tube, Tracheal (W/Wo Connector)
TELEFLEX MEDICAL INC
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+ l
| Date | May 29, 2020 |
| Status | Terminated |
| Reason | 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 | 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 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 di |
| Quantity | 6014 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935842 | RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE Rusch, Inc., May 23, 1995 |