Summary
The FDA issued a Class II for Single Shot Epidural Tray Catalog 1165 by Busse Hospital Disposables, Inc.. Reason: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subjec.
Details
Source
Device Recall
External ID
Z-1151-2022
Action Date
2022-06-08
Status
Terminated
Category
device
Product Description
Single Shot Epidural Tray Catalog 1165
Lot/Code Info: Lot Numbers: 2130290 2131184 UDI: 00849233006485
Quantity Affected: 20 units
Reason for Recall
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-22
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 184 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-1151-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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