B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 1
Summary
The FDA issued a Class II for B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardia by Medical Action Industries, Inc. 306. Reason: The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024..
Details
Source
Device Recall
External ID
Z-0265-2023
Action Date
2022-11-30
Status
Terminated
Category
device
Product Description
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Lot/Code Info: UDI/DI 10809160283875, Batch/Lot number 298442
Quantity Affected: 240 cases of 20 units
Reason for Recall
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Distribution
US Nationwide distribution in the state of Pennsylvania.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-15
Company
Arden, NC
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 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medical Action Industries, Inc. 306 has 8 FDA actions in our database, including 8 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 (Medical Action Industries, Inc. 306) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medical Action Industries, Inc. 306 have FDA actions?
Medical Action Industries, Inc. 306 has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0265-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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