Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
This recall is currently active, issued October 23, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- September 4, 2024
- Posted
- October 23, 2024
- Recall Number
- Z-0163-2025
- Quantity
- 90 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Lot / Code Info
UDI/DI 40195327429752 (each), 10195327429751 (case), Lot Numbers: 23LBL499
Root Cause
Under Investigation by firm
Action Taken
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.