FDA Device recall Z-1332-2019
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use
- FDA Device
- Class II
- completed
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use by Shippert Medical Technologies, citing the pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1332-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2018-02-02 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shippert Medical Technologies |
| Distribution | US |
Product
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Reason
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Identifiers
| code_info | Lot numbers 61508, 61636, 61683, 61753, 61804, 61812, 61813, 61814, 61815, 61862, 61917, 61949, 61991, 62052, 62089, 62134, and 62156 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1332-2019%22
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