CLASS II Device recall · Reported 8 Sep 2021 · FDA Enforcement Report
Steripath Luer Transport Pack, Gen2, Luer, BD recalled
Magnolia Medical Technologies is recalling Steripath Luer Transport Pack, Gen2, Luer, BD, distributed nationwide in the US. The recall was initiated on 2 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2393-2021
- FDA event ID
- 88338
- Recalling firm
- Magnolia Medical Technologies, Seattle, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2021
- FDA classified
- 31 Aug 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 2 Aug 2021 | Recall initiated by company | |
| 31 Aug 2021 | Classified by FDA | +29 days |
| 8 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A
Nationwide AlabamaColoradoFloridaGeorgiaIllinoisIndianaMarylandMichiganNebraskaNew YorkPennsylvaniaSouth CarolinaTexasVirginiaWest VirginiaWyoming
Questions about this recall
Why was it recalled?
Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
Which lots are affected?
Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037
Where was it sold?
U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Magnolia Medical Technologies
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Steripath Gen2 Blood Collection System recalled | Magnolia Medical Technologies | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |