Class 2 Device Recall Puritan HydraFlock Sterile Flocked Collection Device

• Date Initiated by Firm: February 21, 2024
• Date Posted: March 28, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1391-2024
• Recall Event ID: 94087
• Product Classification: Applicator, absorbent tipped, sterile - Product Code KXG
• Product: HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
• Code Information: Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014
• Recalling Firm/ Manufacturer: Puritan Medical Products Company, Llc; 31 School St; Guilford ME 04443-6388
• For Additional Information Contact: Kevin Wrigley; 207-876-3311
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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 sales@puritanmedproducts.com.
• Quantity in Commerce: 465 boxes x 500 units per box = 232,500 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.