FDA Medical Device Recalls (openFDA)
Shippert Medical Technologies: 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.
- Recall number
- Z-1335-2019
- Recalling firm
- Shippert Medical Technologies
- 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.
- Status
- Completed
- Initiated
- 2018-02-02
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Packaging process control
- Action
- 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.
- 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,
- Lot, serial or model codes
- 61471, 61625, 61754, 61840, 61945, 61950, 62135, 62137, and 62157
- 510(k) numbers
- ["K092482"]
- PMA numbers
- not on file
- Product code
- MUU
- Firm FEI
- 3008719017
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28