CLASS II Device recall · Reported 5 Jun 2019 · FDA Enforcement Report
Rusch Lasertube (Rubber) recalled by Teleflex Medical
Teleflex Medical is recalling Rusch Lasertube (Rubber), distributed nationwide in the US. The recall was initiated on 1 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1683-2019
- FDA event ID
- 82552
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2019
- FDA classified
- 29 May 2019
- Reported
- 5 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 1 Apr 2019 | Recall initiated by company | |
| 29 May 2019 | Classified by FDA | +58 days |
| 5 Jun 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
Where it was distributed
Nationwide
Questions about this recall
Is Rusch Lasertube (Rubber) recalled?
Yes. Teleflex Medical recalled Rusch Lasertube (Rubber) on 1 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1683-2019.
Why was it recalled?
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Which lots are affected?
Lot Numbers: 14151, 14161, 14171, 14201, 14211, 14231, 14261, 14271, 14291, 14451, 14461, 14491, 14511, 15041, 15081, 15091, 15101, 15131, 15161, 15201, 15211, 15221, 15241, 15251, 15361, 15381, 15391, 15411, 15431, 15441, 15461, 15491, 15501, 16041, 16051, 16061, 16081, 16091, 16111, 16121, 16141, 16161, 16171, 16191, 16201, 16221, 16231, 16241, 16251, 16261, 16281, 16291, 16301, 16351, 16361, 16371, 16381, 16391, 16401, 16421, 16431, 16441, 16451, 16471, 16481, 16501, 16511, 17021, 17041, 17051, 17061, 17071, 17081, 17091, 17101, 17121, 17131, 17161, 17171, 17181, 17191, 17201, 17211, 17231, 17271, 17281, 17301, 17311, 17361, 17371, 17391, 17421, 17431, 17441, 17451, 17461, 17471, 17481, 17491, 17501, 17511, 18021, 18031, 18041, 18051, 18061, 18071, 18081, 18091, 18101, 18111, 18121, 18131, 18141, 18151, 18171, 18191, 18201, 18231, 18241, 18271, 18351, 18361, 18381, 18401, 18421, 18431, 18441, 14141, 14161, 14171, 14201, 14211, 14231, 14261, 14271, 14281, 14291, 14301, 14311, 14361, 14431, 14441, 14461, 14471, 14481, 14501, 14511, 15041, 15051, 15071, 15081, 15091, 15111, 15121, 15161, 15191, 15211, 15231, 15251, 15311, 15361, 15371
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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