Recall Z-2706-2024 ยท PPB Foley Catheter Kit (Excludes Hiv Testing)
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
| Date | Aug 22, 2024 (initiated Mar 22, 2024) |
| Status | Open, Classified |
| Reason | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees. |
| Quantity | 3400 units |
| Distribution | Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.