The BioZorb LP Marker is an implantable radiopaque recall
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised…
Why was The BioZorb LP Marker is an implantable radiopaque recalled?
Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022.
- Product
- The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised…
- Recalling firm
- Hologic, Inc
- Quantity
- 233
- Distribution
- US Nationwide distribution including in the states of FL, IL, MD, NJ, AZ, TX, WA, VA, OK, NC, NH, GA, CA, CT, OH, CO, MI, MO, KS, TN, ID, MS, MT, AL, OR, IA, PA, MA.
- Recall date
- October 12, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)