Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
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-0171-2025
- Quantity
- 194 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
a) REF DYNJ44114, UDI/DI 40888277202055 (each), 10888277202054 (case), Lot Numbers: 24ABB398; b) REF DYNJ82663B, UDI/DI 40195327544325 (each), 10195327544324 (case), Lot Numbers: 23LBV498
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.