Smiths Medical Portex Loss of Resistance Device Lacks Sterilization and Reuse Labeling
Smiths Medical ASD Inc. is recalling the Portex Loss of Resistance Device because product labeling lacks information on sterilization procedures and does not prohibit reuse. The recall affects 3,420 devices distributed internationally.
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: This is an FDA Class II medical device recall involving missing sterilization and reuse prohibition labeling. No illnesses or injuries have been reported. The hazard qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Portex Loss of Resistance Device (REF 100/398/000) because the device labeling lacks required information about proper sterilization procedures and does not include a prohibition against reuse.
The missing sterilization and reuse prohibition information on the device labeling creates potential risk in clinical settings. Loss of Resistance Devices are medical instruments used in procedures, and proper sterilization guidance and explicit reuse prohibitions are essential for safe device use.
The recall affects 3,420 devices with lot numbers 3980977, 3986734, 3994302, 3994303, and 4001003. These devices were distributed to Canada, Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, and United Arab Emirates.
The recalled product
- Product
- smiths medical portex Loss of Resistance Device, REF 100/398/000
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 3,420
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 (4)
- Lot Numbers: 3980977
- 3986734
- 3994302
- 3994303 and 4001003
Distribution
Distribution scope not specified by the agency.
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