FDA Medical devices recall ·
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK recall
- Recall number
- Z-0640-2025
- Date
- (initiated October 9, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12847 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 was it recalled?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
84OJG 1) REF CDS780202P, UDI/DI 10195327096458 (each) 40195327096459 (case), Lot Numbers: 22IMA512, 22IMA513, 22FMD852, 22GME200, 22FMH471, 22LMA065; 2) REF CDS780202Q, UDI/DI 10195327265304 (each) 40195327265305 (case), Lot Numbers: 22LMA225, 23EME852, 23DME052; 3) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23FMI343, 4) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers: 22EBB662, 22JBR840, 23ABG194, 23DBM361, 23BBR105; 5) REF CDS981327Q, UDI/DI 10195327080365 (each) 40195327080366 (case), Lot Numbers: 22GMH480, 22FMF883, 22FMH830, 23JMG480, 23CMF104, 23BMH848, 23BMG193, 23BMG197, 23KMF371, 23IMG472; 6) REF CDS983186J, UDI/DI 10195327105624 (each) 40195327105625 (case), Lot Numbers: 23CBO871, 22EBV250, 22EBU143, 23DBA498, 23DBO557; 7) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers: 23GMC512, 23GMC697; 8) REF DYNJ0406347M, UDI/DI 10195327510701 (each) 40195327510702 (case), Lot Numbers: 23JMH534; 9) REF DYNJ0484186M, UDI/DI 10195327046057 (each) 40195327046058 (case), Lot Numbers: 22EBF993, 22GBB271, 22FBF013; 10) REF DYNJ0484186N, UDI/DI 10195327204150 (each) 40195327204151 (case), Lot Numbers: 22JBX539, 22IBD332, 23FBB054, 23DBI625, 23GBL780; 11) REF DYNJ0843121K, UDI/DI 10195327286491 (each) 40195327286492 (case), Lot Numbers: 23IDC125, 23EDB879, 23DDB255, 23GDA826; 12) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers: 22EBN168, 22EBB079, 22H
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0640-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.