Recall Z-2492-2021
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
Soft Tissue Biopsy Needles
Codes / lots: Model MGK11210, Lot Numbers: 5216C Model MGK11410, Lot Numbers: 5216C, 1217B, 3620D Model MGK11413, Lot Numbers: 5216C Model MGK11415, Lot Numbers: 3620D Model MGK11610, Lot Numbers: 5216C, 3620D Model MGK11615, Lot Numbers: 3620D Model MGK11616, Lot Numbers: 5216C, 1217B Model MGK11620, Lot Numbers: 1617A Model MGK11810, Lot Numbers: 5216C Model MGK11816, Lot Numbers: 5216C Model MGK11820, Lot Numbers: 5216C, 1217B, 4617 Model MGK11825, Lot Numbers: 5216C, 1217B, 3620D, 3620E Model PD01415, Lot Numbers: 3620D, 3620E Model PD01416, Lot Numbers: 5216C, 1417A Model PD01420, Lot Numbers: 5216C Model PD01610, Lot Numbers: 5216C, 0817A, 0818, 1618A, 1918A, 3620D, 3620E Model PD01615, Lot Numbers: 3620D, 3620E Model PD01616, Lot Numbers: 5216C, 1417A Model PD01620, Lot Numbers: 5216C Model PD01810, Lot Numbers: 5216C, 0817A, 0817A, 1617A, 0818, 1618A, 1918A Model PD01816, Lot Numbers: 5216C, 0817A, 0817A, 1617A Model PD01820, Lot Numbers: 5216C, 2217A, 2217A Model PD02007, Lot Numbers: 1617A, 2217A, 0119 Model PD02010, Lot Numbers: 5216C, 0817A, 2217A, 1918A Model PD02016, Lot Numbers: 5216C, 0817A, 2217A Model PD02020, Lot Numbers: 5216C, 0817A Model PD0PP1407, Lot Numbers: 0718 Model…
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-2492-2021
- Initiated
- August 5, 2021
- Terminated
- May 4, 2026
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 20,129 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-2493-2021 Class II | General Manual surgical instrumentSterility assurance may be compromised. | 08/05/2021Terminated |