Recall Z-1335-2019
Shippert Medical Technologies · initiated February 2, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Codes / lots: 61471, 61625, 61754, 61840, 61945, 61950, 62135, 62137, and 62157
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.
FDA-determined cause: Packaging process control
Action taken
Letters dated 1/9/2018 were issued beginning 2/2/2018 via registered mail and Fed Ex explaining the reason for recall, risk to health, description of how to recognize the device failed, and actions to be taken.
Details
- Recall number
- Z-1335-2019
- Initiated
- February 2, 2018
- Product code
- MUU – System, Suction, Lipoplasty
- Quantity
- 6,553 units were distributed for all catalog numbers
- Distribution
- 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,
- Recalling firm
- Shippert Medical Technologies, Centennial, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1330-2019 Class II | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use.…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | 02/02/2018Completed |
| Z-1331-2019 Class II | Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use.…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | 02/02/2018Completed |
| Z-1332-2019 Class II | Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use.…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | 02/02/2018Completed |
| Z-1333-2019 Class II | Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient… | 02/02/2018Completed |
| Z-1334-2019 Class II | Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient… | 02/02/2018Completed |
| Z-1336-2019 Class II | Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | 02/02/2018Completed |