Zion Crossroads, VA, United States
Boss Instruments, Ltd. recalls
1 recall recorded since 2018, most recently on 26 June 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 June 2020
- Terminated
- 20 July 2021
- Reason
- The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2767-2020
- 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 proc
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.