Recall Z-1391-2024 ยท KXG Applicator, Absorbent Tipped, Sterile
Puritan Medical Products Company, Llc
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
| Date | Mar 28, 2024 (initiated Feb 21, 2024) |
| Status | Open, Classified |
| 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. |
| Root 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 diag |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.