Recall Z-0326-2023— Busse Hospital Disposables, Inc.

Class II · Ongoing

Class II FDA medical device recall by Busse Hospital Disposables, Inc., initiated 2022-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1. Reason: 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.

Recalling firm
Busse Hospital Disposables, Inc.
Classification
Class II
Status
Ongoing
Initiated
2022-10-21
Firm location
Hauppauge, NY, United States

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.