Recall Z-2489-2021
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
Bone Marrow Transplantation biopsy needle
Codes / lots: Model PI1535/100, Lot Numbers: 3620D Model PIL1410/75, Lot Numbers: 1617A Model PIL1435/100, Lot Numbers: 1617A Model PIL1510/75, Lot Numbers: 3620D, 3620E Model PIL1535/100, Lot Numbers: 5216C, 3620D Model PIL1610/75, Lot Numbers: 3620D, 3620E, 4120 Model PIL1635/100, Lot Numbers: 5216C Model PIL1835/100, Lot Numbers: 5216C Model PIP1410/50, Lot Numbers: 1617A Model PIP1430/70, Lot Numbers: 1617A Model PIP1510/50, Lot Numbers: 1217B, 1618A Model PIP1530/70, Lot Numbers: 1617A Model PIP1630/70, Lot Numbers: 1617A Model PIP1810/50, Lot Numbers: 0818, 1618A Model PIP1830/70, Lot Numbers: 1617A Model PJ0810, Lot Numbers: 3620D Model PJ1110, Lot Numbers: 3620D, 4920B Model PJ1306, Lot Numbers: 3620D Model PJE1110, Lot Numbers: 5216, 5216C, 1417A, 3517C, 4617, 0818, 1418, 2518A, 4018, 4318D, 5018, 1119B, 1119C, 1119A, 3620D Model PJK21110, Lot Numbers: 3616C, 3620D Model PJK21115, Lot Numbers: 3416C Model PJK21310, Lot Numbers: 3416C, 3620D Model PJT0810, Lot Numbers: 4220B, 4320D, 4320D Model PJT0815, Lot Numbers: 4220D, 4320E Model PJT1110, Lot Numbers: 1417A, 3620D, 3620D, 3620D, 4220B, 4220B, 4220B, 4220A, 4320F, 4320D Model PJT1115, Lot Numbers: 3620D, 4220B, 4320D Model PJT1306…
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-2489-2021
- Initiated
- August 5, 2021
- Terminated
- May 4, 2026
- Product code
- DWO – Needle, Biopsy, Cardiovascular
- Quantity
- 21,518 units
- Distribution
- Nationwide
- Recalling firm
- M.D.L. S.r.l., Delebio
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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 |
| Z-2493-2021 Class II | General Manual surgical instrumentSterility assurance may be compromised. | 08/05/2021Terminated |