Recall record at a glance
| Official record | Z-2635-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Sep 4, 2024 |
| Recall initiation date | Apr 8, 2024 |
| Quantity | 1,679,067 units in total |
| Location | Northfield, IL, United States |
Official product description
Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NERVE BLOCK ACCESSORY PACK, Pack Number DYNJ0134147D ; 7) UNIVERSAL PROC TRAY-LF, Pack Number DYNJ02120B ; 8) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AJ; 9) CUSTOM BLOCK KEMP PACK-LF , Pack Number DYNJ0371999G ; 10) PAIN MANAGEMENT PACK-LF , Pack Number DYNJ0374104F ; 11) THORASCOPIC - UNIV, Pack Number DYNJ0375880O ; 12) ANGIOGRAPHIC PACK II-LF , Pack Number DYNJ0543507AB; 13) GM ANGIOGRAPHY PACK-LF, Pack Number DYNJ0621584Y ; 14) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0689247S ; 15) PERI NEURO BLOCK PACK-LF, Pack Number DYNJ0703127A ; 16) MAJOR HEAD/NECK PACK-LF , Pack Number DYNJ0826705L ; 17) STANDARD BLOCK PACK-LF, Pack Number DYNJ0957047C ; 18) STANDARD BLOCK PACK-LF, Pack Number DYNJ0957047CH; 19) NECK PACK , Pack Number DYNJ17213C ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ20085K ; 21) ANGIO CATH PACK-MARY IMMACULAT, Pack Number DYNJ24517D ; 22) PAIN MANAGEMENT , Pack Number DYNJ26879A ; 23) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJ32412B ; 24) UNIVERSAL BLOCK TRAY, Pack Number DYNJ32680; 25) ANGIOGRAM TRAY, Pack Number DYNJ33638J ; 26) NERVE BLOCK PACK-LF , Pack Number DYNJ34351B ; 27) PATIENT PREP TRAY , Pack Number DYNJ34489C ; 28) UNIVERSAL MAJOR PACK-LF , Pack Number DYNJ35760B ; 29) BLOCK-LF, Pack Number DYNJ36152A ; 30) TRANSFORAMINAL PACK , Pack Number DYNJ36406B ; 31) UNIVERSAL BLOCK TRAY, Pack Number DYNJ36781; 32) RADIOFREQUENCY PACK , Pack Number DYNJ37338C ; 33) MAJOR NEURO VCH , Pack Number DYNJ39218D ; 34) NEPHROSTOMY PACK, Pack Number DYNJ41069A ; 35) CVOR ANGIOGRAPHY PACK-LF, Pack Number DYNJ42367B ; 36) BLOCK PACK, Pack Number DYNJ44205C ; 37) NECK PACK-LF, Pack Number DYNJ46059A ; 38) UNIVERSAL RVHS-LF , Pack Number DYNJ46874; 39) BLOCK KIT-LF, Pack Number DYNJ47338; 40) ANGIO KIT , Pack Number DYNJ48177A ; 41) UNIVERSAL CORE DR RUNNELS PACK, Pack Number DYNJ52230; 42) ANGIO PACK-LF , Pack Number DYNJ52898B ; 43) NEPHROLOGY PACK , Pack Number DYNJ59089; 44) MAJOR ANGIO , Pack Number DYNJ59301A ; 45) NIJHER PAIN PACK, Pack Number DYNJ62009C; 46) NIJHER PAIN PACK, Pack Number DYNJ62009C ; 47) O NEILL PAIN PACK , Pack Number DYNJ62011C ; 48) NEPHROLOGY PACK , Pack Number DYNJ62930; 49) NEPHROLOGY PACK , Pack Number DYNJ63200A ; 50) NEURO GOODIE PACK - DUNN, Pack Number DYNJ64570; 51) THROMBECTOMY PACK - NEUROS, Pack Number DYNJ64580; 52) RADIOFREQUENCY, Pack Number DYNJ68289; 53) EPIDURAL PACK, Pack Number DYNJ68840A; 54) EPIDURAL PACK , Pack Number DYNJ68840A ; 55) NEURO , Pack Number DYNJ901405K; 56) NEURO LUMBAR, Pack Number DYNJ904111G; 57) NERVE BLOCK TRAY-LF , Pack Number DYNJRA0022A; 58) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0031B; 59) UNIVERSAL BLOCK PAIN PK , Pack Number DYNJRA0041 ; 60) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044 ; 61) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044A; 62) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044B; 63) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0050A; 64) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0051B; 65) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0052 ; 66) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0087B; 67) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0104B; 68) UNIVERSAL BLOCK SPINAL-LF , Pack Number DYNJRA0105B; 69) UNIVERSAL BLOCK TRAY-LF, Pack Number DYNJRA0110A; 70) UNIVERSAL BLOCK TRAY-LF, Pack Number DYNJRA0111; 71) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0139D; 72) PAIN CLINIC , Pack Number DYNJRA0173B; 73) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0179 ; 74) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0186C; 75) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0187B; 76) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0191C; 77) NERVE BLOCK TRAY (FACET)-LF , Pack Number DYNJRA0207A; 78) NERVE
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.
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