Home / Recalls / Medical Devices
Boss Instruments, Ltd. recalls BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic clean
Recalled August 12, 2020 · FDA recall Z-2767-2020 · Boss Instruments
Hazard
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure. · FDA Class II
Units
96 devices
Sold at
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.
Description
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Product
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.
Manufacturer(s)
Boss Instruments, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →