FDA Device recall Z-1270-2020
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4… by Teleflex Medical, citing there is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1270-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-13 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | n/a |
Product
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-56K p) 6.0 mm, REF MDP-60K
Reason
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Identifiers
| code_info | a) Teleflex Medical Disposable Aortic Punch, 2.8 mm, REF DP-28K Lot Numbers: 74A1501140, 74B1602364, 74E1700597, 74G1…a) Teleflex Medical Disposable Aortic Punch, 2.8 mm, REF DP-28K Lot Numbers: 74A1501140, 74B1602364, 74E1700597, 74G1602599, 74H1900357, 74L1501549, 74A1601253, 74B1900832, 74E1800886, 74G1700636, 74J1501218, 74L1501977, 74A1601254, 74C1501113, 74E1802643, 74G1700637, 74J1501754, 74L1501978, 74A1602903, 74C1600966, 74E1901667, 74G1700718, 74J1501755, 74L1600387, 74A1602904, 74C1600972, 74F1502019, 74G1900066, 74J1601180, 74L1600389, 74A1603168, 74C1600976, 74F1600350, 74G1900340, 74J1603181, 74L1602761, 74A1603170, 74C1600977, 74F1602476, 74G1902629, 74J1800844, 74L1700357, 74A1701154, 74C1702793, 74F1602477, 74G1903756, 74K1500475, 74L1800444, 74A1802567, 74C1702794, 74F1702731, 74H1502508, 74K1500476, 74L1803409, 74A1903113, 74C1800357, 74F1800411, 74H1502510, 74K1501684, 74L1901787, 74A1903146, 74D1600123, 74F1802291, 74H1601384, 74K1501685, 74M1601318, 74B1501366, 74D1601266, 74F1802292, 74H1602748, 74K1900124, 74M1602080, 74B1501710, 74D1601524, 74G1500954, 74H1700589, 74K190012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1270-2020%22
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