FDA Recall
Open, Classified
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Recall: Z-0465-2025
·
Initiated October 21, 2024
Recall
- Recall Number
- Z-0465-2025
- Event Number
- 95671
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- LRW
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 21, 2024
- Posted
- November 14, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Reason
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Action
This is an expansion of recall RES 92881, which was originally initiated on April 30, 2024. Additional impacted customers were identified and notified on October 7, 2024. Customers were instructed to destroy any affected product on hand. The firm will issue credit for affected product.
Distribution
US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.
Quantity
69,611