Teleflex Medical Europe Ltd Recall 88353
Description: RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
Teleflex Medical Europe Ltd Recall 88353 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2319-2021 |
| Event ID | 88353 |
| Event Description | RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 32410 units |
| Recall Reason | The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. |
| Device Classification | 20210825 |
| Device Code Info | a) 170050, Lot Numbers: KME20K2551, KME20L1089, KME20L2371, KME21A2064, KME21B2498, KME21C0488 b) 170055, Lot Numbers: KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21A0383, KME21A1901, KME21B2682, KME21C2708 c) 170060, Lot Numbers: KME20L1487, KME20L2379, KME20M0494, KME21A0384, KME21A1482, KME21C0293 d) 170065, Lot Numbers: KME20K0938, KME20K2623, KME20L0487, KME20L1705, KME20M1578, KME20M1751, KME20M2709, KME21A0385, KME21A1812, KME21B1670, KME21B2499, KME21B2500, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 e) 170070, Lot Numbers: KME20K2544, KME20L0053, KME20L0055, KME20L0942, KME20L2372, KME20M0381, KME20M0665, KME20M1103, KME20M1754, KME20M1755, KME21A0893, KME21A2264, KME21B1074, KME21B1075, KME21C0463, KME21C0464, KME21C1027, KME21C1422, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 f) 170075, Lot Numbers: KME20K1352, KME20L1132, KME20M0033, KME20M0382, KME20M1149, KME20M1225, KME20M1227, KME20M1537, KME20M2881, KME20M2882, KME21A0824, KME21A1161, KME21A1813, KME21B0813, KME21C0212, KME21C0213, KME21C1594, KME21C1895, KME21C2855, KME21C3294, KME21C3295 g) 170080, Lot Numbers: KME20L0396, KME20L1278, KME20L1279, KME20L2830, KME20M0847 , KME21A0386, KME21A2800, KME21A2801, KME21B1245, KME21B1752, KME21B2156, KME21C0465, KME21C0533, KME21C2826 h) 170085, Lot Numbers: KME20L0398, KME20L2376, KME20M3247, KME21A1894, KME21C0298, KME21C2385 i) 170090, Lot Numbers: KME20L0625 j) 170095, Lot Numbers: KME20M0384, KME21B0407 |
| Center Classification Date | 20210819 |
| Recall Initiation Date | 20210716 |
| Recalling Firm | Teleflex Medical Europe Ltd |
| Initial Notification | Letter |
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