The Recall Desk
HighFDA (Devices)·Z-1336-2019·Announced 2019-05-22

Shippert Medical Technologies Recalls Tissu-Trans Syringe Fill 360 Due to Pouch Integrity Concerns

Shippert Medical Technologies is recalling Tissu-Trans Syringe Fill 360 devices because the sterile pouch integrity cannot be assured without visual examination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile medical device where the integrity of the sterile barrier is compromised, posing a risk of infection or harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Shippert Medical Technologies is recalling Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use medical devices. The recall is due to a potential cut or hole in the pouch, which means the integrity of the sterile product cannot be assured without a visual examination.

The recall involves 6,553 units distributed nationwide, including Puerto Rico, as well as government and 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 the United Kingdom.

The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the defect.

The recalled product

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.
Manufacturer
Shippert Medical Technologies
Category
Medical Device — Syringe / Infusion
Hazard
Affected units
6,553

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 61656

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by Shippert Medical Technologies under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Shippert Medical Technologies

See all →

Same hazard · sterility compromise

See all →