FDAFDA · Food and drugs·Recall number Z-2442-2024
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040; 6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097; 7) PAIN TRAY, Pack Number DYNJRA2230; 8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A; 9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856; 10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A; 11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047; 12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048
Published August 14, 2024 · Recall initiated: April 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
- Lot
- DYNJRA0960C , Lot Number 23CBH823 ; DYNJRA0960C , Lot Number 23EBC905 ; DYNJRA0960C , Lot Number 23EBV028 ; DYNJRA0960C , Lot Number 23HBO071 ; DYNJRA0960C , Lot Number 24BBI322 ; DYNJRA1268C , Lot Number 22GLB081 ; DYNJRA1268C , Lot Number 22HLA566 ; DYNJRA1268C , Lot Number 22ILA092 ; DYNJRA1268C , Lot Number 22LLA800 ; DYNJRA1268C , Lot Number 23DLA368 ; DYNJRA1268C , Lot Number 23FLA942 ; DYNJRA1268C , Lot Number 23GLA321 ; DYNJRA1268C , Lot Number 23HLA910 ; DYNJRA1268C , Lot Number 23ILA593 ; DYNJRA1638C , Lot Number 23EBA854 ; DYNJRA1638C , Lot Number 23GBE493 ; DYNJRA1638C , Lot Number 23KBJ159 ; DYNJRA1928 , Lot Number 22EBD354 ; DYNJRA1928 , Lot Number 22JBO947 ; DYNJRA1928 , Lot Number 23CBO440 ; DYNJRA1928 , Lot Number 23HBK783 ; DYNJRA1928 , Lot Number 23JBI435 ; DYNJRA1928 , Lot Number 23LBM602 ; DYNJRA1928 , Lot Number 24ABQ693 ; DYNJRA2040 , Lot Number 23CBH893 ; DYNJRA2040 , Lot Number 23HBX547 ; DYNJRA2040 , Lot Number 23JBN538 ; DYNJRA2040 , Lot Number 24ABQ696 ; DYNJRA2040 , Lot Number 24CBG746 ; DYNJRA2097 , Lot Number 23BBO995 ; DYNJRA2230 , Lot Number 23JBU321 ; DYNJRA2230 , Lot Number 23LBC389 ; PAIN1766A , Lot Number 23FLB123 ; PAIN1766A , Lot Number 23GLA313 ; PAIN1766A , Lot Number 24ALA302 ; PAIN1766A , Lot Number 24BLA659 ; PAIN1766A , Lot Number 24BLA888 ; PAIN1766A , Lot Number 24BLA889 ; PAIN1766A , Lot Number 24BLA998 ; PAIN1766A , Lot Number 24CLA003 ; PAIN1766A , Lot Number 24CLA078 ; PAIN1856 , Lot Number 22JLB162 ; PAIN1856 , Lot Number 22LLA409 ; PAIN1856A , Lot Number 23HLB303 ; PAIN1856A , Lot Number 24BLB005 ; PAIN1856A , Lot Number 24BLA682 ; PAIN2047 , Lot Number 24BBH932 ; PAIN2048 , Lot Number 24BBF612
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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