Steripath Luer Transport Pack Gen2 Recalled for Incorrect Instructions
Magnolia Medical Technologies is recalling 9,400 units of Steripath Luer Transport Pack Gen2 because they were shipped with incorrect Transfer Adapter Instructions For Use (IFU).
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 2/5 (Moderate).
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: This is a Class II medical device recall where the sole identified issue is incorrect product labeling (Instructions For Use). The recall notice does not identify any adverse events or injury reports. The hazard is theoretical, related to potential improper device use resulting from incorrect instructions. This aligns with Score 2's criterion of 'minor labeling errors.'
Plain-English summary
Magnolia Medical Technologies, Inc. is recalling 9,400 units of Steripath Luer Transport Pack, Gen2, Luer, BD (Catalog #27BD-EN, Part #P00165-000, Lot #9448037). The product was distributed nationwide to the states of Alabama, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Nebraska, New York, Pennsylvania, South Carolina, Texas, Virginia, West Virginia, and Wyoming.
The product was shipped with incorrect Transfer Adapter Instructions For Use (IFU). This holder/adapter assembly is used to access specimens from catheter ports for blood or urine collection using BD Vacutainer collection tubes.
Healthcare facilities that have received affected product should verify they have the correct instructions and ensure proper use procedures are followed before continued use. For more information or if you have received affected units, contact Magnolia Medical Technologies, Inc.
The recalled product
- Product
- Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.
- Manufacturer
- Magnolia Medical Technologies, Inc.
- Hazard
- Affected units
- 9,400
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)
- Catalog #: 27BD-EN
- Part #: P00165-000 Lot #9448037
Distribution
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