Guilford, ME, United States
Puritan Medical Products Company, Llc recalls
1 recall recorded since 2018, most recently on 21 February 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 February 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1391-2024
- HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.