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Recall Observatory FDA recall evidence

Device 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.

Z-2767-2020

June 26, 2020

Class II

Product summary

Firm
Boss Instruments, Ltd.
Event
Event 86040
Status
Terminated
Classification
Class II
Quantity
96 devices
Official record key
device-enforcement:Z-2767-2020

Official wording

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

Code information: Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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