Z-0326-2023Class II

Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1

Name: Z-0326-2023 Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Creator: Busse Hospital Disposables, Inc.
Published: 2022-10-21
License: https://open.fda.gov/license/

Busse Hospital Disposables / initiated 2022-10-21 / Open, Classified / root cause: design

FDA source

Busse Hospital Disposables, Inc. began a recall of Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 on 2022-10-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0326-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-21
Posted: 2022-11-29
Recalling firm: Busse Hospital Disposables
Product: Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Product code: OGJ Nerve Block Tray
Reason for recall: 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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 40 cases
Distribution: TX
Product codes and lots: UDI-DI: (01) 00849233016705 Lot Number: 2230458

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0326-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0325-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-07	2022-11-29
Z-0326-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-07	2022-11-29

Product code OGJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)