M.D.L. S.r.l. Recall 88430
Description: Bone Marrow Transplantation biopsy needle
M.D.L. S.r.l. Recall 88430 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2489-2021 |
Event ID | 88430 |
Event Description | Bone Marrow Transplantation biopsy needle |
Product Type | Devices |
Distribution | Nationwide |
Quantity | 21,518 units |
Recall Reason | Sterility assurance may be compromised. |
Device Classification | 20210929 |
Device Code Info | 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, Lot Numbers: 1417A, 3517C, 3620D, 3620E, 4220B, 4320D Model PJT1310, Lot Numbers: 3620D, 4220B, 4420A, 4320D Model PS0810, Lot Numbers: 2518A, 1119A Model PS1110, Lot Numbers: 4316, 4316A, 4316B, 4316B, 2618, 4018, 3620D Model PS1115, Lot Numbers: 3620D Model PS1306, Lot Numbers: 3620D Model PS1310, Lot Numbers: 3916, 3620D |
Center Classification Date | 20210920 |
Recall Initiation Date | 20210805 |
Recalling Firm | M.D.L. S.r.l. |
Initial Notification | Letter |
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