Recall record at a glance
| Official record | Z-3042-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Sep 18, 2024 |
| Recall initiation date | Apr 8, 2024 |
| Location | Northfield, IL, United States |
Official product description
Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS780056L ; 6) SHUNT CDS-LF, Pack Number CDS780103K ; 7) NEURO CDS , Pack Number CDS780108T ; 8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ; 9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ; 10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ; 11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ; 12) NEURO CDS , Pack Number CDS780162AA; 13) NEURO CDS , Pack Number CDS780162AB; 14) NEURO CDS , Pack Number CDS780162AC; 15) NEURO CDS , Pack Number CDS780162AD; 16) NEURO CDS , Pack Number CDS780162X ; 17) NEURO CDS , Pack Number CDS780162Y ; 18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ; 19) BASIC NEURO PACK, Pack Number CDS780202L ; 20) BASIC NEURO PACK, Pack Number CDS780202O ; 21) BASIC NEURO PACK, Pack Number CDS780202P ; 22) BASIC NEURO PACK, Pack Number CDS780202Q ; 23) BASIC NEURO PACK, Pack Number CDS780202R ; 24) NEURO-LAMI CDS, Pack Number CDS780208D ; 25) NEURO-LAMI CDS, Pack Number CDS780208F ; 26) NEURO CDS, Pack Number CDS780230K; 27) NEURO CDS , Pack Number CDS780230K ; 28) VP SHUNT, Pack Number CDS840193U ; 29) NEURO CDS-LF, Pack Number CDS980853N ; 30) VP SHUNT CDS-LF , Pack Number CDS981084K ; 31) VP SHUNT CDS-LF , Pack Number CDS981084L ; 32) VP SHUNT CDS-LF , Pack Number CDS981084M ; 33) NEURO KIT , Pack Number CDS981327N ; 34) NEURO KIT , Pack Number CDS981327O ; 35) NEURO KIT , Pack Number CDS981327P ; 36) NERVE STIMULATOR, Pack Number CDS981579N ; 37) NEURO MINOR CDS , Pack Number CDS981708K ; 38) VP SHUNT CDS, Pack Number CDS981740F ; 39) VP SHUNT CDS, Pack Number CDS981740J ; 40) VP SHUNT CDS, Pack Number CDS981740K ; 41) VP SHUNT CDS, Pack Number CDS981740KH; 42) MICRO DISC CDS, Pack Number CDS981886P ; 43) MICRO DISC CDS, Pack Number CDS981886R ; 44) MICRO DISC CDS, Pack Number CDS981886S ; 45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ; 46) NEURO CDS , Pack Number CDS982603L ; 47) NEURO CDS , Pack Number CDS982603M ; 48) NEURO CDS , Pack Number CDS982603N ; 49) NEURO SPINE CDS , Pack Number CDS982683Q ; 50) MAJOR NEURO , Pack Number CDS982704K ; 51) MAJOR NEURO , Pack Number CDS982704M ; 52) MAJOR NEURO , Pack Number CDS982704N ; 53) NEURO CDS CHS-LF, Pack Number CDS982745D ; 54) NEURO CDS CHS-LF, Pack Number CDS982745F ; 55) NEURO CDS CHS-LF, Pack Number CDS982745G ; 56) AV SHUNT CDS, Pack Number CDS983098D ; 57) AV SHUNT CDS, Pack Number CDS983098F ; 58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ; 59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ; 60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ; 61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ; 62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ; 63) VP SHUNT, Pack Number CDS983366J ; 64) VP SHUNT, Pack Number CDS983366M ; 65) VP SHUNT, Pack Number CDS983366N ; 66) VP SHUNT, Pack Number CDS983366P ; 67) NEURO CDS-LF, Pack Number CDS983383F ; 68) NEURO CDS-LF, Pack Number CDS983383G ; 69) NEURO CDS-LF, Pack Number CDS983383I ; 70) NEURO CDS-LF, Pack Number CDS983383J ; 71) AV SHUNT CDS, Pack Number CDS983792C ; 72) AV SHUNT CDS, Pack Number CDS983792D ; 73) ANTERIOR NEURO CDS, Pack Number CDS983882C ; 74) ANTERIOR NEURO CDS, Pack Number CDS983882D ; 75) POSTERIOR NEURO CDS , Pack Number CDS983885C ; 76) POSTERIOR NEURO CDS , Pack Number CDS983885D ; 77) POSTERIOR NEURO CDS , Pack Number CDS983885F ; 78) NEURO CDS , Pack Number CDS983981D ; 79) NEURO CDS , Pack Number CDS983981F ; 80) NEURO CDS , Pack Number CDS983981I ; 81) NEURO CDS , Pack Number CDS983981J ; 82) NEURO CDS , Pack Number CDS983981K ; 83) NEURO CDS , Pack Number CDS983981L ; 84) CRANI NEURO CDS , Pack Number CDS984172F ; 85) PUH NEURO EEA CDS , Pack Number CDS984297G ; 86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ; 87) ME
Why the product was recalled
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution information
Worldwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.