Tissu-Trans Syringe Fill 360 — Class II medical device recall Z-1336-2019
Completed recall by Shippert Medical Technologies, reported 2019-05-22, distributed nationwide. The pouch integrity of the sterile product can't be assured without a visual examination due to possibly conta
| Recall number | Z-1336-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shippert Medical Technologies, Centennial, CO, United States |
| Recall initiated | 2018-02-02 |
| Classified | 2019-05-15 |
| Reported by FDA | 2019-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, DE, DK, ES, GB, GR, IN, IT, JP, NL, NZ, SA, SE, ZA |
| Quantity | 6,553 units |
| Reason classes | sterility |
| Model numbers | 3-TT-SFILL, 360 |
Product
Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1336-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.