RecallDepth

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

Company
Busse Hospital Disposables, Inc.
Recall Initiated
October 21, 2022
Posted
November 29, 2022
Recall Number
Z-0326-2023
Quantity
40 cases
Firm Location
Hauppauge, NY

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

Distribution

TX

Lot / Code Info

UDI-DI: (01) 00849233016705 Lot Number: 2230458

Root Cause

Device Design

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.

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