FDA Device recall Z-0134-2024
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation by B Braun Medical, citing 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 hea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0134-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-26 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Reason
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.
Identifiers
| code_info | UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2024%22
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