FDAJune 26, 2020device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
What to do
FDA enforcement status: Terminated
Brands named
boss instrumentsboss
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-1592026-03-02
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-1492026-03-02
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