FDA Device recall 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, Product Code 102004-000050 c) I.D.…
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II 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.… by Teleflex Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2533-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-29 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | US |
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.
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.
Identifiers
| code_info | a) I.D. mm 4,0, Product Code 102004-000040, Lot numbers: 19491, 19501, 19511, 20021, 20041, 20091 b) I.D. mm 5,0, P…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2533-2020%22
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