Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Summary
The FDA issued a Class II for Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 by Busse Hospital Disposables, Inc.. 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 produ.
Details
Source
Device Recall
External ID
Z-0325-2023
Action Date
2022-12-07
Status
Ongoing
Category
device
Product Description
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Lot/Code Info: UDI-DI: (01)00849233016712 Lot Number: 2230276
Quantity Affected: 80 cases
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-21
Company
Hauppauge, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Busse Hospital Disposables, Inc. has 63 FDA actions in our database, including 63 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Busse Hospital Disposables, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Busse Hospital Disposables, Inc. have FDA actions?
Busse Hospital Disposables, Inc. has 63 FDA actions in our database, including 63 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0325-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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