Z-2767-2020 Class II Terminated
FDA device recall Z-2767-2020 was initiated by Boss Instruments, Ltd. on June 26, 2020 and is designated Class II. Reason for recall: The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure. The recall status is terminated (terminated July 20, 2021). Affected quantity: 96 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- June 26, 2020
- Termination Date
- July 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 devices
Product Description
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.
Reason for Recall
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
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.
Code Information
Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383