FDAFDA · Food and drugs·Recall number Z-1683-2019
RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
Published June 5, 2019 · Recall initiated: April 1, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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