Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL,
FDA device recall Z-0930-2023 · posted 2023-01-11 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
- Action taken
- Medline notified customers on about 11/18/2022, via letter. Customers were instructed to immediately check stock for the affected item number and the affected lot numbers, and to destroy all affected product. Customers were also instructed to notify customers if the product was further distributed and to complete a response form. On 02/06/2023, the recall was expanded to include additional item numbers and consignees were notified.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GFA
- Quantity affected
- 76,053 units
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA.
- Date initiated
- 2022-11-18
- Date posted
- 2023-01-11
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.