The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1335-2019·Announced 2019-05-22

Shippert Medical Technologies Recalls Tissu-Trans MEGA 1500 Due to Pouch Integrity Concerns

Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 sterile pouches because a cut or hole may compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 specific injuries or illnesses are reported in the source text.

Plain-English summary

Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 sterile, disposable, one-patient use products. 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 affected products are identified by catalog number 3-TT-MEGA 1500 and lot codes 61471, 61625, 61754, 61840, 61945, 61950, 62135, 62137, and 62157. A total of 6,553 units were distributed nationwide, including Puerto Rico, as well as to government and military entities. Foreign distribution occurred in Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.

Healthcare providers and consumers should stop using the affected products and contact Shippert Medical Technologies for further instructions.

The recalled product

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.
Manufacturer
Shippert Medical Technologies
Category
Medical Device — Surgical/Disposable
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 (9)

  • 61471
  • 61625
  • 61754
  • 61840
  • 61945
  • 61950
  • 62135
  • 62137
  • and 62157

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 →

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