Z-1332-2019 Class II
FDA device recall Z-1332-2019 was initiated by Shippert Medical Technologies on February 2, 2018 and is designated Class II. 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. Affected quantity: 6,553 units were distributed for all catalog numbers.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- February 2, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,553 units were distributed for all catalog numbers
Product Description
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 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.
Distribution Pattern
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,
Code Information
Lot numbers 61508, 61636, 61683, 61753, 61804, 61812, 61813, 61814, 61815, 61862, 61917, 61949, 61991, 62052, 62089, 62134, and 62156