Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ32727A; a) VASCULAR PACK-LF, REF DYNJ32915B; a) SUAREZ AVR/MVR PACK, REF DYNJ35884C; a) VALVE ACCESSORY PACK, REF DYNJ36241K; a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B; a) EP PACK, REF DYNJ40488; a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G; a) PACEMAKER TEGH-LF, REF DYNJ46745A; a) VEIN AND LASER PACK, REF DYNJ49874; a) DR NACKMAN VEIN PACK, REF DYNJ56235; a) NEUROVASCULAR PACK, REF DYNJ66718A; a) VEIN TRAY, REF DYNJ69012C; a) LOOP RECORDER-LF, REF DYNJ69196; a) U BAR DRAPE, REF DYNJ80064; a) ENDO, REF DYNJ903814B; a) CARDIAC PROCEDURE, REF DYNJ908126; a) CARDIAC PROCEDURE, REF DYNJ908126; a) VASCULAR EXTREMITY PACK, REF SYNJ10322A; a) VASCULAR EXTREMITY, REF SYNJ910026A

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) REF CDS983202I, UDI/DI 40195327164677 (each), 10195327164676 (case), Lot Numbers: 23LBI662; b) REF DYNDC2486A, UDI/DI 40889942648055 (each). 10889942648054 (case), Lot Numbers: 23LBM830; c) REF DYNJ01201L, UDI/DI 40888277744807 (each), 10888277744806 (case), Lot Numbers: 23LBP126; d) REF DYNJ0537343G, UDI/DI 40193489517072 (each), 10193489517071 (case), Lot Numbers: 23LBP442; e) REF DYNJ32727A, UDI/DI 40888277036346 (each), 10888277036345 (case), Lot Numbers: 24ABB296; f) REF DYNJ32915B, UDI/DI 40195327486427 (each), 10195327486426 (case), Lot Numbers: 23LBK382; g) REF DYNJ35884C, UDI/DI 40195327547609 (each), 10195327547608 (case), Lot Numbers: 24ABF463; h) REF DYNJ36241K, UDI/DI 40195327555949 (each), 10195327555948 (case), Lot Numbers: 23LBL339; i) REF DYNJ38084B, UDI/DI 40889942670841 (each), 10889942670840 (case), Lot Numbers: 23LBR317; j) REF DYNJ40488, UDI/DI 40884389861685 (each), 10884389861684 (case), Lot Numbers: 23LBL628; k) REF DYNJ41925G, UDI/DI 40193489677349 (each), 10193489677348 (case), Lot Numbers: 24ABA421; l) REF DYNJ46745A, UDI/DI 40889942279297 (each), 10889942279296 (case), Lot Numbers: 23KBB860; m) REF DYNJ49874, UDI/DI 40888277890603 (each), 10888277890602 (case), Lot Numbers: 23LBL699; n) REF DYNJ56235, UDI/DI 40889942621553 (each), 10889942621552 (case), Lot Numbers: 23EBD843A; o) REF DYNJ66718A, UDI/DI 40193489916332 (each), 10193489916331 (case), Lot Numbers: 24ABN915; p) REF DYNJ69012C, UDI/DI 40195327515943 (each), 10195327515942 (case), Lot Numbers: 23LBQ949; q) REF DYNJ69196, UDI/DI 40193489906234 (each), 10193489906233 (case), Lot Numbers: 23LBR843; r) REF DYNJ80064, UDI/DI 40195327009251 (each), 10195327009250 (case), Lot Numbers: 23LBP174; s) REF DYNJ903814B, UDI/DI 40195327333769 (each), 10195327333768 (case), Lot Numbers: 23LBS865; t) REF DYNJ908126, UDI/DI 40193489980111 (each), 10193489980110 (case), Lot Numbers: 24BBA256; u) REF DYNJ908126, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABN040; v) REF SYNJ10322A, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABD377; w) REF SYNJ910026A, UDI/DI 40193489374491 (each), 10193489374490 (case), Lot Numbers: 24ABV352
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ32727A; a) VASCULAR PACK-LF, REF DYNJ32915B; a) SUAREZ AVR/MVR PACK, REF DYNJ35884C; a) VALVE ACCESSORY PACK, REF DYNJ36241K; a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B; a) EP PACK, REF DYNJ40488; a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G; a) PACEMAKER TEGH-LF, REF DYNJ46745A; a) VEIN AND LASER PACK, REF DYNJ49874; a) DR NACKMAN VEIN PACK, REF DYNJ56235; a) NEUROVASCULAR PACK, REF DYNJ66718A; a) VEIN TRAY, REF DYNJ69012C; a) LOOP RECORDER-LF, REF DYNJ69196; a) U BAR DRAPE, REF DYNJ80064; a) ENDO, REF DYNJ903814B; a) CARDIAC PROCEDURE, REF DYNJ908126; a) CARDIAC PROCEDURE, REF DYNJ908126; a) VASCULAR EXTREMITY PACK, REF SYNJ10322A; a) VASCULAR EXTREMITY, REF SYNJ910026A

Product Codes/Lot Numbers:

a) REF CDS983202I, UDI/DI 40195327164677 (each), 10195327164676 (case), Lot Numbers: 23LBI662; b) REF DYNDC2486A, UDI/DI 40889942648055 (each). 10889942648054 (case), Lot Numbers: 23LBM830; c) REF DYNJ01201L, UDI/DI 40888277744807 (each), 10888277744806 (case), Lot Numbers: 23LBP126; d) REF DYNJ0537343G, UDI/DI 40193489517072 (each), 10193489517071 (case), Lot Numbers: 23LBP442; e) REF DYNJ32727A, UDI/DI 40888277036346 (each), 10888277036345 (case), Lot Numbers: 24ABB296; f) REF DYNJ32915B, UDI/DI 40195327486427 (each), 10195327486426 (case), Lot Numbers: 23LBK382; g) REF DYNJ35884C, UDI/DI 40195327547609 (each), 10195327547608 (case), Lot Numbers: 24ABF463; h) REF DYNJ36241K, UDI/DI 40195327555949 (each), 10195327555948 (case), Lot Numbers: 23LBL339; i) REF DYNJ38084B, UDI/DI 40889942670841 (each), 10889942670840 (case), Lot Numbers: 23LBR317; j) REF DYNJ40488, UDI/DI 40884389861685 (each), 10884389861684 (case), Lot Numbers: 23LBL628; k) REF DYNJ41925G, UDI/DI 40193489677349 (each), 10193489677348 (case), Lot Numbers: 24ABA421; l) REF DYNJ46745A, UDI/DI 40889942279297 (each), 10889942279296 (case), Lot Numbers: 23KBB860; m) REF DYNJ49874, UDI/DI 40888277890603 (each), 10888277890602 (case), Lot Numbers: 23LBL699; n) REF DYNJ56235, UDI/DI 40889942621553 (each), 10889942621552 (case), Lot Numbers: 23EBD843A; o) REF DYNJ66718A, UDI/DI 40193489916332 (each), 10193489916331 (case), Lot Numbers: 24ABN915; p) REF DYNJ69012C, UDI/DI 40195327515943 (each), 10195327515942 (case), Lot Numbers: 23LBQ949; q) REF DYNJ69196, UDI/DI 40193489906234 (each), 10193489906233 (case), Lot Numbers: 23LBR843; r) REF DYNJ80064, UDI/DI 40195327009251 (each), 10195327009250 (case), Lot Numbers: 23LBP174; s) REF DYNJ903814B, UDI/DI 40195327333769 (each), 10195327333768 (case), Lot Numbers: 23LBS865; t) REF DYNJ908126, UDI/DI 40193489980111 (each), 10193489980110 (case), Lot Numbers: 24BBA256; u) REF DYNJ908126, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABN040; v) REF SYNJ10322A, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABD377; w) REF SYNJ910026A, UDI/DI 40193489374491 (each), 10193489374490 (case), Lot Numbers: 24ABV352

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0156-2025

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