9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
Summary
The FDA issued a Class II for 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants by ENDO Pharmaceuticals Solutions, Inc.. Reason: No expiration dates printed on the packaging.
Details
Source
Device Recall
External ID
Z-0774-2023
Action Date
2023-01-11
Status
Ongoing
Category
device
Product Description
9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
Lot/Code Info: UDI: N/A Lot Numbers: 58672, 58673
Quantity Affected: 2603 units
Reason for Recall
No expiration dates printed on the packaging
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-08
Company
Cranbury, NJ
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 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (ENDO Pharmaceuticals Solutions, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ENDO Pharmaceuticals Solutions, Inc. have FDA actions?
This is the only FDA action we have on record for ENDO Pharmaceuticals Solutions, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0774-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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