Puritan HydroFlock Collection Device Distributed with Wrong Product Code
Puritan Medical Products distributed HydroFlock Sterile Flocked Collection Devices labeled as Part Number 25-3317-H, Lot S1014 that actually contain product code 25-3317-U. Approximately 232,500 units were affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall with no reported illnesses or injuries falls under the criterion of 'risk-of-harm products where injury has not yet been reported.' The FDA's Class II classification indicates a potential health risk despite the absence of reported adverse events.
Plain-English summary
Puritan Medical Products Company, LLC is recalling approximately 232,500 HydroFlock Sterile Flocked Collection Devices that were distributed with incorrect labeling. Boxes labeled as Part Number 25-3317-H, Lot S1014 actually contained product code 25-3317-U. The company discovered the mislabeling through a customer complaint.
The recalled devices were distributed nationwide in 20 US states (AL, CA, FL, GA, IA, ID, IL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, OK, PA, TX, VA) and internationally to Canada, Puerto Rico, China, and Thailand. The affected devices are identified by Part Number 25-3317-H, UDI/DI 00609576330322, and Lot Number S1014.
Consumers and healthcare providers with this product should verify their inventory against the recalled lot information using Part Number 25-3317-H, UDI/DI 00609576330322, and Lot S1014.
The recalled product
- Product
- HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
- Manufacturer
- Puritan Medical Products Company, Llc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part number: 25-3317-H
- UDI/DI: 00609576330322
- Serial/Lot Number: S1014
Distribution
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