FDA Medical Device Recalls (openFDA)
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables: Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
- Recall number
- Z-0544-2018
- Recalling firm
- Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
- Product
- Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
- Status
- Terminated
- Initiated
- 2017-06-27
- Posted
- not on file
- Terminated
- 2020-07-27
- Reason
- BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
- Root cause
- Nonconforming Material/Component
- Action
- On June 27, 2017, Busse Hospital Disposables distributed Urgent Medical Device Recall notices and Response Forms to their customers via courier service. A copy of the supplier's recall notice was also provided to customers. Customers were advised to conduct the following: " Discontinue use of needle immediately. " Please check your inventory and cease distribution immediately. " If you have distributed the above products, please contact your customers and inform them of this recall immediately. " Contact Busse Hospital Disposables for a Return Good Authorization number. " Complete and Return the Response Form via fax to 631-435-2849 or via email to: ijacobo@busseinc.com. Customers with questions may call 631-435-4711, ext. 254.
- Quantity
- 75 cases
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers/Expiration Dates: 1) 1730650/Expiration Date: 10/30/2021; 2) 1630921/Expiration Date: 11/02/2020; 3) 1631124/Expiration Date: 10/30/2020; 4) 1631386/Expiration Date: 05/30/2021; 5) 1631679/Expiration Date: 05/30/2021
- 510(k) numbers
- ["K032432","K110883"]
- PMA numbers
- not on file
- Product code
- PWY
- Firm FEI
- 2433012
- Firm city
- Hauppauge
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28