FDA Medical Device Recalls (openFDA)
MICROVENTION INC.: Aspiration Syringe Kit, REF: MVSK60
- Recall number
- Z-0202-2022
- Recalling firm
- MICROVENTION INC.
- Product
- Aspiration Syringe Kit, REF: MVSK60
- Status
- Terminated
- Initiated
- 2021-10-20
- Posted
- not on file
- Terminated
- 2024-05-15
- Reason
- Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
- Root cause
- Under Investigation by firm
- Action
- On 10/20/21, recall notices were sent to customers. Customers were asked to identify and quarantine all impacted kits. Complete and return the response form. Return affected devices to the manufacturer including a copy of the completed response form. The following contact information was provided to customers with additional questions: FieldAssurance@microvention.com, and 714-247-8143 or 949-501-0355, Hours: Monday -Friday PST 8:00-5:00 pm.
- Quantity
- 33
- Distribution
- US Nationwide distribution in the states of AL, NY, NV.
- Lot, serial or model codes
- Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461
- 510(k) numbers
- ["K994253"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3013556777
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28