Busse SPINE INJECTION TRAY-Intended as a nerve block recallZ-0326-2023 · Busse Hospital Disposables, Inc. · initiated Oct 21, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Busse Hospital Disposables, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
FDA root cause category: Device Design
What the company is doing
Busse issued Product Recall Notification Letter dated 10/20/22 to Distributor; End User via Email on 10/21/2022 and Certified Mail on 10/24/2022 Letter states reason for recall, health risk and action to take: 1. Immediately check your inventory for the lots listed above. 2. Do not use the drape included in the product with the lot number(s) listed above. 3. Complete the enclosed Response Form within the next 10 days and return via email to [email protected] even if you have no affected product on hand. a. If you do have product in stock, destroy the drape following your facility policy.
Recall details
- Recall number
- Z-0326-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 21, 2022
- Posted by the FDA
- Nov 29, 2022
- Recalling firm
- Busse Hospital Disposables, Inc.
- Quantity
- 40 cases
- Product code
- OGJ
- Distribution
- TX
Product description
Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Code information (models, lots, serial numbers)
UDI-DI: (01) 00849233016705 Lot Number: 2230458
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Busse Hospital Disposables 8563Robert Busse & CO., Inc. · Nerve Block Tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91079).
- Z-0325-2023 · Open, ClassifiedBusse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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