CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report
Allergan Universal Fill Kit recalled by B. Braun Medical
B. Braun Medical is recalling Allergan Universal Fill Kit, distributed nationwide in the US. The recall was initiated on 26 Sep 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-0134-2024
- FDA event ID
- 93074
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2023
- FDA classified
- 3 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Breast Implants
Timeline
| 26 Sep 2023 | Recall initiated by company | |
| 3 Nov 2023 | Classified by FDA | +38 days |
| 15 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Questions about this recall
Why was it recalled?
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Which lots are affected?
UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
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.
Other products in this recall event
8 other products · FDA event 93074This product is part of a recall event; the main page for the event is Terumo 60" Tube Set W/High Crack Chk Vlv, Article No. 7S3070 recalled.
More recalls from B. Braun Medical
All 448| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | B Braun Safsite Injection Site, RV1000NC Safsite Valve W/O Extra Cap recalled | B Braun Medical | Packaging Defects | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | 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 |
Other Breast Implants recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | BBraun Medical Winged INF recalled | B Braun Medical | Device Malfunction | Nationwide |
| Device | CLASS II | B. Braun Winged Infusion, Single PK recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |