The Recall Desk
ModerateFDA (Devices)·Z-1543-2013·Announced 2013-06-19

Utah Medical Products Recalls Deltran Disposable Pressure Transducer Kits

Utah Medical Products is recalling 1,800 Deltran Disposable Pressure Transducer Kits due to complaints regarding the packaging integrity of the sterile devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves packaging integrity of sterile devices, which is a potential risk for contamination, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Utah Medical Products, Inc. is recalling 1,800 Deltran Disposable Pressure Transducer Kits (DPT Kits). These are extracorporeal disposable pressure transducers and tubing sets with integral stopcock and flush devices, used for invasive blood pressure monitoring in humans and animals.

The recall was initiated due to complaints related to the packaging integrity of the sterile packaged devices. The affected products are identified by part number DPT-248A and lot number 1122508.

The products were distributed worldwide, including nationwide in the United States (specifically in Missouri, Nebraska, Kentucky, Florida, Ohio, and New York) and in countries such as Colombia, Brazil, Venezuela, the West Indies, Latin America, and Ecuador. Some distribution occurred through a US direct consignee exporter. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items.

The recalled product

Product
Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during
Manufacturer
Utah Medical Products, Inc
Category
Medical Device — Invasive Monitoring
Hazard
Affected units
1,800

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 (2)

  • Part number DPT-248A
  • lot number 1122508.

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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