BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container cl
Summary
The FDA issued a Class II for BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to by Becton Dickinson & Company. Reason: Holes in product packaging impacts package integrity and may compromise sterility..
Details
Source
Device Recall
External ID
Z-0179-2022
Action Date
2021-11-03
Status
Terminated
Category
device
Product Description
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
Lot/Code Info: Lot Number: 1111347 Exp. Date: 4/30/2026 UDI: 10382903058225
Quantity Affected: 8,000 units
Reason for Recall
Holes in product packaging impacts package integrity and may compromise sterility.
Distribution
TX
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-27
Company
Franklin Lakes, 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 124 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Becton Dickinson & Company has 39 FDA actions in our database, including 39 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 (Becton Dickinson & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Company have FDA actions?
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0179-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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