FDA Device recall Z-1328-2014
5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Acc…
- FDA Device
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Acc… by Teleflex Medical, citing complaints of leakage of insufflation gas through the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1328-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-11 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No. 410944S; 5/10/12 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 412944; 5/10/12 Weck Vista Universal Balloon Open Access Port - Long Length (100 mm), Catalog No. 412944L. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Reason
Complaints of leakage of insufflation gas through the device.
Identifiers
| code_info | Lots Catalog No. 410944 - 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200…Lots Catalog No. 410944 - 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622; Catalog No. 410944L - 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, 01A1300202, Catalog No. 410944S - 01L1200460, 01K1200619, 01L1200515, 01E1300137; Catalog No. 412944 01J1200241, 01K1200066, 01K1200622; Catalog No. 412944L - 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, 01E1300436 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2014%22
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