Recall record at a glance
| Official record | Z-0640-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Dec 11, 2024 |
| Recall initiation date | Oct 9, 2024 |
| Quantity | 12847 units |
| Location | Northfield, IL, United States |
Official product description
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, REF DYNJ0038440C; 8) NEURO PACK-LF, REF DYNJ0406347M; 9) NEURO-LF, REF DYNJ0484186M; 10) NEURO-LF, REF DYNJ0484186N; 11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K; 12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 13) NEURO-ORTHO EXTRAS, REF DYNJ44882L; 14) NEURO PACK, REF DYNJ57785B; 15) NEURO PACK, REF DYNJ60825B; 16) CHRISTUS MC NEURO PACK, REF DYNJ61157C; 17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C; 18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C; 19) AFCH SHUNT, REF DYNJ63317C; 20) NEURO SPINE PK, REF DYNJ63319D; 21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D; 22) DBS PACK, REF DYNJ63322A; 23) NEURO LAM, REF DYNJ64188B; 24) PACK,V-P SHUNT, REF DYNJ65472B; 25) NEURO PK, REF DYNJ66735A; 26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B; 27) NEURO PACK, REF DYNJ68558A; 28) NEURO PACK, REF DYNJ69019C; 29) VP SHUNT, REF DYNJ81866A; 30) VP SHUNT, REF DYNJ81866B; 31) VP SHUNT, REF DYNJ81866C; 32) NEURO PACK, REF DYNJ84058A; 33) NEURO, REF DYNJ900420O; 34) CRANIO / NEURO / SPINE, REF DYNJ901072G; 35) CRANIO / NEURO / SPINE, REF DYNJ901072I; 36) LAMINECTOMY, REF DYNJ903870F; 37) MINOR NEURO, REF DYNJ904859C; 38) MINOR NEURO, REF DYNJ904859D; 39) MINOR NEURO, REF DYNJ904859F; 40) NEURO, REF DYNJ904861B; 41) NEURO, REF DYNJ904861D; 42) NEURO, REF DYNJ904861F; 43) NEURO, REF DYNJ904861G; 44) KIT V P SHUNT, REF DYNJ908835A; 45) GENERAL NEURO, REF DYNJ909744
Why the product was recalled
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution information
US Nationwide 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.
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