medical Class II Updated 2020-08-12

Boss Instruments, Ltd. recalls BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part N

Recalled 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.


Hazard / Issue

The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383
View official government recall

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