Reported Feb 13, 2019 · Ongoing
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product…
Richard Wolf GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Richard Wolf GmbH · Pforzheimer Str. 32 · Knittlingen · N/A
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents |
| 2 | The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems |
| 3 | Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation. |
- Lot codes and dates
- All lot numbers manufactured from October 30, 2006 to August 15, 2018, with affected Product and Lot Numbers distributed worldwide -
- Product Number (Lot Numbers)
139 of 139 codes
825200641 (12719241074548118651613648051262505126916513131481296901133042713829411321674133957812655011344236126141513724371353961M054680M118520100349210589791287750)825200842 (11895161074551131985512989131057370M054700M118540)825201041 (12698241277860118652011952611230705134040112536611263078128852011865201227431136855013760181382289131616711041631074553130732912962851332473131985610534001337541M054720M118550)825201241 (118583113725001364881123836512730171302457
- Nationwide - Part Number (Lot Numbers)
109 of 109 codes
82520.0641 (10589791074548133957810034921313148M05468011865161271924126250512691651296901136480513304271344236M118520128775013539611382941)82520.0841 (107455013337711323968M0546901281667127410512411651053398126982012436111248730126250612888561298436M1185301362251118582911985151338467137816612536581296284)82520.0842 (M118540M05470011895161319855)82520.1041 (1074553131985613161671277860M05472010534001269824123070512536611263078137601812885201332473M11855013375411186520
- Amount recalled
- 873 units worldwide (468 units within the US)
Where it was sold
Why it was recalled
There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.
This product could cause temporary or reversible health problems — stop using it.
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