PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-0
Pending LLM rewrite. Source: FDA_DEVICE Z-0533-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
The recalled product
- Product
- PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lot(Expiration): IN4802/K/00884450638385/I3138883(20-FEB-2028)
- I3150031(27-FEB-2028)
- I3161209(10-MAR-2028)
- I3161210(08-APR-2028)
- I3161211(17-MAR-2028)
- I3172451(30-NOV-2026)
- IN4802/T/00884450860113/I3135188(30-NOV-2026
- I3170171(10-MAR-2028
- IN4918/A/00884450638521/I3146050(20-FEB-2028)
- I3200779(19-MAY-2028)
- IN7802/C/00884450498743/H3143753(30-NOV-2026)
- H3162387(14-MAR-2028)
- H3183068(31-MAR-2028)
- H3189446(29-FEB-2028)
- H3213617(31-MAY-2028)
- IN8802/C/00884450621417/H3141570(02-FEB-2028)
- H3143769(03-FEB-2028)
- H3143770(31-DEC-2026)
- H3143771(03-FEB-2028)
- H3143772(03-FEB-2028)
Distribution
Distributed in 49 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
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