MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
This recall is currently active, issued September 18, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- August 3, 2023
- Posted
- September 18, 2023
- Recall Number
- Z-2595-2023
- Quantity
- 324,451 devices
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore
Lot / Code Info
UDI/DI 10080196847273, all lots
Root Cause
Under Investigation by firm
Action Taken
Medline Industries issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem with the device, the potential hazard, and requested the following: Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. Distributors or those who resold or transferred the product were directed to notify their customers and have them destroy any affected product. If you have any questions, please contact the Recall Department at 866-359-1704.