Recall Z-2491-2021
M.D.L. S.r.l. · initiated August 5, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mammary Nodules Localization
Codes / lots: Model Number PN2010, Lots: 3620D Model Number PN2012, Lots: 1317 Model Number PN2015, Lots: 3620D Model Number PNA2005, Lots: 5216C Model Number PNA2010, Lots: 3620D Model Number PNA2015, Lots: 3620D Model Number PNAX2005, Lots: 5216C Model Number PNS2010, Lots: 3620D Model Number PNS2015, Lots: 3620D Model Number PNX2010, Lots: 0817A Model Number PR2005, Lots: 5216C, 4920B Model Number PR2007, Lots: 5216C Model Number PR2010, Lots: 3620D Model Number PR2015, Lots: 3620D
Reason for recall
Sterility assurance may be compromised.
FDA-determined 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.
Details
- Recall number
- Z-2491-2021
- Initiated
- August 5, 2021
- Terminated
- May 4, 2026
- Product code
- GDF – Guide, Needle, Surgical
- Quantity
- 320 units
- Distribution
- Nationwide
- Recalling firm
- M.D.L. S.r.l., Delebio
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2489-2021 Class II | Bone Marrow Transplantation biopsy needleSterility assurance may be compromised. | 08/05/2021Terminated |
| Z-2490-2021 Class II | Aspirated Cyto-Histological Biopsy needleSterility assurance may be compromised. | 08/05/2021Terminated |
| Z-2492-2021 Class II | Soft Tissue Biopsy NeedlesSterility assurance may be compromised. | 08/05/2021Terminated |
| Z-2493-2021 Class II | General Manual surgical instrumentSterility assurance may be compromised. | 08/05/2021Terminated |