CLASS II ONGOING Device recall · Reported 4 Oct 2023 · FDA Enforcement Report
B.Braun Norm-ject Luer Lock Solo recalled by B. Braun Medical
B. Braun Medical is recalling B.Braun Norm-ject Luer Lock Solo, Sterile-Intended to be used to deliver (inject) or, distributed nationwide in the US. The recall was initiated on 7 Aug 2023 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-2644-2023
- FDA event ID
- 92910
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Aug 2023
- FDA classified
- 27 Sep 2023
- Reported
- 4 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 7 Aug 2023 | Recall initiated by company | |
| 27 Sep 2023 | Classified by FDA | +51 days |
| 4 Oct 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The sterile blister packaging may be damaged, and sterility may be compromised
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02
Where it was distributed
US Nationwide distribution in the state of VA.
Questions about this recall
Is B.Braun Norm-ject Luer Lock Solo, Sterile-Intended to be used to deliver (inject) or recalled?
Yes. B. Braun Medical recalled B.Braun Norm-ject Luer Lock Solo, Sterile-Intended to be used to deliver (inject) or on 7 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-2644-2023.
Why was it recalled?
The sterile blister packaging may be damaged, and sterility may be compromised
Which lots are affected?
UDI-DI: 04046955597185 Lot Numbers: 22M21C8, 23A09C8
Where was it sold?
US Nationwide distribution in the state of VA.
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 21 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 B. Braun Medical
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | Nationwide |
| Drug | ANNOUNCED | B. Braun 9% Sodium Chloride Injection USP, in a PAB Container recalledB. Braun | B. Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |