FDAFDA · Food and drugs·Recall number Z-1336-2019
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.
Published May 22, 2019 · Recall initiated: February 2, 2018
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shippert Medical Technologies
- Distributor
- Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,
- Lot
- 61656
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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