Aspirated Cyto-Histological Biopsy needle
This recall is currently active, issued August 5, 2021. It was issued by M.D.L. S.R.L. Via Tavani N. 1/A Delebio Italy.
- Recall Initiated
- August 5, 2021
- Recall Number
- Z-2490-2021
- Quantity
- 2750 devices
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility assurance may be compromised.
Distribution
Nationwide
Lot / Code Info
Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A
Root Cause
Other
Action Taken
The firm disseminated an URGENT: MEDICAL DEVICE RECALL notice on 08/05/2021 by email. The notice explained the issue and requested the return of any unused products. Distributors were instructed to notify their customers.