FDAFDA · Food and drugs·Recall number Z-2767-2020
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.
Published August 12, 2020 · Recall initiated: June 26, 2020
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 tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Boss Instruments, Ltd.
- Distributor
- Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.
- Lot
- Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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