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Recall Observatory FDA recall evidence

Device product

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

Z-0326-2023

October 21, 2022

Class II

Product summary

Firm
Busse Hospital Disposables, Inc.
Event
Event 91079
Status
Ongoing
Classification
Class II
Quantity
40 cases
Official record key
device-enforcement:Z-0326-2023

Official wording

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

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

Distribution pattern: TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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