human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
HUMAN MED AG · The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather th…
Open FDA's page for this record- Cfres ID
- 212112
- Product res number
- Z-1251-2025
- Event date initiated
- 2024-10-18
- Event date posted
- 2025-02-28
- Recall status
- Open, Classified
- Res event number
- 96137
- Product code
- QPB
- Product description
- human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
- Code info
- Lot number 24-20198, UDI (01)04260170881014(11)240611(17)270611(10)24-20198; and Lot number 23-19612, UDI (01)04260170881014(11)240109(17)270109(10)23-19612.
- Firm FEI number
- 3003587189
- Recalling firm
- HUMAN MED AG
- Address 1
- Wilhelm-Hennemann-Str. 9 9 wilhelm-hennemann-str.
- City
- Schwerin
- Country
- Germany
- Root cause description
- Process control
- Product quantity
- 775 devices
- Distribution pattern
- US Nationwide distribution in the state of FL.
- Reason for recall
The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
- Action
The recalling firm issued a Field Safety Notice to Distributors dated 10/18/2025 via email explaining the reason for the Field Safety Notice, the potential hazard, and informing the consignee to discontinue delivering the affected products to customers and users and to dispose of the product if still in their warehouse. A Field Safety Notice was enclosed to be issued to the consignee's users and customers who received the affected product from the Distributor. The User and Customer letter dated 10/17/2024 was similar to the Distributor letter except provided instructions to check the spray pattern as instructed in the user manuals prior to using the cannula. If the pattern was not in a flat, fan-shaped pattern, they are not to use the cannula and it should be sorted out and disposed of properly. A confirmation form was enclosed to confirm the cannula has been correctly disposed of and the form was to be sent to the distributor or to the email address provided.
- K numbers
- K082025
- Harmonized identifiers (openFDA)
- Device name
- System, Suction, Lipoplasty For Removal
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.5040
- Device class
- 2
- K number
- K244026, K253396, K063336, K101413, K093067, K252495, K244050, K241835, K082025, K980763, K990602, K981527, K052183, K190551, K190555, K981922, K261710, K113795, K161722, K251944, K981215, K012042, K254135, K220318, K150134, K001803, K012236, K042261, K031881, K121218, K004005, K063235, K192694, K240188, K081039, K200168, K041058, K981172, K992855, K170329 +20 more
- Registration number
- 3007593903, 3002807523, 3007697975, 3011423170, 3018094310, 3038613815, 1222928, 2027804, 2030624, 3030230686, 3022978896, 3009039068, 9680741, 2032809, 2022994, 3008837339, 3009103001, 3004112621, 1000655158, 3004878380, 1058584, 3009420598, 3003587189, 3038715747, 1220246, 3003755939, 2032098, 3008023310, 1047843, 2020601, 1118193, 3044777117, 1045254, 1645337, 3007279404, 3007829657, 1313525, 3011533696, 3014903258, 3005670221 +10 more
- FEI number
- 3007593903, 3002807523, 1000219637, 3007697975, 3018094310, 3038613815, 3004106598, 3030230686, 3022978896, 3009039068, 1000125732, 3008837339, 3009103001, 1000118360, 1000125147, 2022994, 3004112621, 1000655158, 3004878380, 3009420598, 3004169154, 1000120613, 3003587189, 3038715747, 1220246, 3003755939, 3008023310, 1047843, 3002807634, 2020601, 1118193, 3003058448, 1317628, 3044777117, 3007279404, 1045254, 3007829657, 3000206435, 3011533696, 3014903258 +10 more