The Recall Desk
HighFDA (Devices)·Z-1332-2019·Announced 2019-05-22

Shippert Medical Technologies Recalls Tissu-Trans FILTRON 500 Due to Pouch Integrity Concerns

Shippert Medical Technologies is recalling Tissu-Trans FILTRON 500 sterile pouches because a cut or hole in the packaging may compromise the product's sterility.

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 is classified as FDA Class II, and the hazard involves a potential breach of sterility in a medical device, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Shippert Medical Technologies is recalling 6,553 units of Tissu-Trans FILTRON 500, a sterile, disposable, one-patient use medical device. The recall is being conducted because the integrity of the sterile product cannot be assured without a visual examination, as the packaging may contain a cut or hole.

The affected units are identified by specific lot numbers, including 61508, 61636, 61683, 61753, 61804, 61812, 61813, 61814, 61815, 61862, 61917, 61949, 61991, 62052, 62089, 62134, and 62156. Distribution was nationwide, including Puerto Rico, and included government and military channels. The product was also distributed to several foreign countries, including 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 or a return. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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.
Manufacturer
Shippert Medical Technologies
Category
Medical Device — Surgical/Procedural
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 (17)

  • Lot numbers 61508
  • 61636
  • 61683
  • 61753
  • 61804
  • 61812
  • 61813
  • 61814
  • 61815
  • 61862
  • 61917
  • 61949
  • 61991
  • 62052
  • 62089
  • 62134
  • and 62156

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

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Same hazard · sterility compromise

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