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HydroFlock Sterile Flocked Collection Device, Part Number… recallZ-1391-2024 · Puritan Medical Products Company, Llc · initiated Feb 21, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Puritan Medical Products Company, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

URGENT: FIELD SAFETY NOTICE/MEDICAL DEVICE RECALL letters were sent to customers 21-Feb-2024. Customers were instructed to: 1. Carefully read the content of this notification. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification. 3. Document on the Reply Form the number of the affected products currently located at your facility and confirm they have been destroyed. 4. If you have already further processed or utilized this product in a kit, assess the impact of the incorrect collection device on the final medical device / in vitro diagnostic that is distributed. 5. Notify your customers of this field action. Advise your customers to cease use or further distribution of the affected product, destroy kits containing this affected product, and re-review any results already obtained using these collection devices. Please appropriately document your notification process and let us know the end-customer feedback accordingly. 6. Attest that and that you have received and understood this notification and have notified any additional customers you may have distributed to by filling out and returning the completed enclosed Reply Form by 27-Feb-2024. Puritan Medical is coordinating with the applicable Regulatory Agencies. We fully appreciate your prompt cooperation in addressing this situation and working with us to ensure your patients are treated only with safe and effective Puritan products that you have come to rely upon. If you require additional information or on-site support, please do not hesitate to contact Puritan directly at (800) 321-2313 from Monday through Friday or by e-mail at [email protected].

Recall details

Recall number
Z-1391-2024
Status
Open, Classified
Initiated by the company
Feb 21, 2024
Posted by the FDA
Mar 28, 2024
Recalling firm
Puritan Medical Products Company, Llc
Quantity
465 boxes x 500 units per box = 232,500 units
Product code
KXG
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.

Product description

HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.

Code information (models, lots, serial numbers)

Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page