FDA-Device2020-08-12Class II
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.
Boss Instruments, Ltd.
Hazard
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Sold states
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.
Affected count
96 devices
Manufactured in
104 Sommerfield Dr, Zion Crossroads, VA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2767-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief