HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Summary
The FDA issued a Class II for HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. by Puritan Medical Products Company, Llc. Reason: It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 wh.
Details
Source
Device Recall
External ID
Z-1391-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Lot/Code Info: Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;
Quantity Affected: 465 boxes x 500 units per box = 232,500 units
Reason for Recall
It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
Distribution
Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IA, ID, IL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, OK, PA, TX, VA and the countries of Canada, P.R. China and Thailand.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-21
Company
Guilford, ME
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 163 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 (Puritan Medical Products Company, Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Puritan Medical Products Company, Llc have FDA actions?
This is the only FDA action we have on record for Puritan Medical Products Company, Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1391-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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