Recall Z-2493-2021
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
General Manual surgical instrument
Codes / lots: Model MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A
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-2493-2021
- Initiated
- August 5, 2021
- Terminated
- May 4, 2026
- Product code
- MJG – Device, Percutaneous, Biopsy
- Quantity
- 4120 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-2491-2021 Class II | Mammary Nodules LocalizationSterility assurance may be compromised. | 08/05/2021Terminated |
| Z-2492-2021 Class II | Soft Tissue Biopsy NeedlesSterility assurance may be compromised. | 08/05/2021Terminated |