FDA Device recall Z-1269-2020
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 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-1269-2020 |
| 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
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Reason
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Identifiers
| code_info | Lot Number 74B1500674 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Teleflex Medical
- (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile
FDA Device · Class II · 2022-06-01 · Teleflex Medical - (1) Teleflex Flex tube, Product #20011, sterile
FDA Device · Class II · 2022-06-01 · Teleflex Medical - Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Per…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-…
FDA Device · Class I · 2022-02-23 · Teleflex Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1269-2020%22
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