Reported Aug 12, 2020 · Terminated
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic…
Boss Instruments, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boss Instruments, Ltd. · 104 Sommerfield Dr · Zion Crossroads, VA · 22942-7009
Is this the product you have?
- BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503
- and 51-2503 - Product UsageEndoscopic 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
- Lot codes and dates
- Lot Numbers
003514150042539100374008077021950880181208802271003832110038476500418258088042040990009309900383
- Lot Numbers
- Amount recalled
- 96 devices
Where it was sold
Why it was recalled
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
This product could cause temporary or reversible health problems — stop using it.
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