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U.S. Department of Health and Human Services

Class 2 Device Recall Endoscopic Cleaning Brush

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  Class 2 Device Recall Endoscopic Cleaning Brush see related information
Date Initiated by Firm June 26, 2020
Create Date August 05, 2020
Recall Status1 Terminated 3 on July 20, 2021
Recall Number Z-2767-2020
Recall Event ID 86040
Product Classification Holder, needle, gastroenterologic - Product Code FHQ
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.
Code Information Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383
Recalling Firm/
Manufacturer		 Boss Instruments, Ltd.
104 Sommerfield Dr
Zion Crossroads VA 22942-7009
For Additional Information Contact James Gano
540-832-5000
Manufacturer 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.
FDA Determined
Cause 2		 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 that we can assign you a returned goods authorization number (RGA#) and further assist you in return of the product noted above. Please note that replacements will be provided on a first come first serve bases and we are working with our supplier to make all replacement units available as soon as possible. We recognize that the withdrawal of these DeBakey needle holders may be disruptive to your facility and we apologize for any inconvenience this may cause. If you have any addition questions regarding this action or to report any customer complaints, please contact me at jamesgano@bossinst.com.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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