Recall Z-2767-2020 ยท FHQ Holder, Needle, Gastroenterologic
Boss Instruments, Ltd.
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.
| Date | Jun 26, 2020 |
| Status | Terminated |
| Reason | The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Voluntary Medical Device Recall notification letters dated 6/26/20 were emailed to customers. Please distribute this information to any of your customers who may have these units in their possession and ask that they return them to Boss Instruments Ltd. for full credit by no later than August 3l5t, 2020. We also ask that any remaining units of this lot held in your current inventory be returned to us immediately for full credit. Please contact me directly at the email address listed below, call our toll free number: 1-540-832-5000 or contact your normal customer account manager so th |
| Quantity | 96 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.