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

FDA device recall Z-0326-2023 · posted 2022-11-29 · Open, Classified

Recall details

Recalling firm

Busse Hospital Disposables, Inc.

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

Action taken

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 csabillon@busseinc.com even if you have no affected product on hand. a. If you do have product in stock, destroy the drape following your facility policy.

Root cause

Device Design

Status

Open, Classified

Product code

OGJ

Quantity affected

40 cases

Distribution

TX

Date initiated

2022-10-21

Date posted

2022-11-29

Location

Hauppauge, NY