Recall Z-2767-2020— Boss Instruments, Ltd.
Class II · Terminated
Class II FDA medical device recall by Boss Instruments, Ltd., initiated 2020-06-26, terminated 2021-07-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure..
- Recalling firm
- Boss Instruments, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-26
- Terminated
- 2021-07-20
- Firm location
- Zion Crossroads, VA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.