Recall Z-1117-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated November 15, 2023
Class I – dangerous or defective products that could cause serious health problems or death
Product
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f) DRSG CHANGE TRAY W/ CHG, REF DT21460BH; g) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i) PEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j) PORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k) PORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l) PORT ACCESS PACK-LF, REF DYNJ0352159D; m) PORT DRESSING CHANGE KIT, REF DT22810; n) PORT DRESSING CHANGE TRAY, REF DT20640B; o) PORT DRESSING CHANGE TRAY, REF DYNDC3052A; p) PORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s) SALINE GAUZE DRESSING TRAY, REF DYNDA2937; t) SALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u) SALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v) ADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w) A-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x) CENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y) CENTRAL LINE DRESSING KIT, REF EBSI1088A; z) CENTRAL LINE DRESSING KIT, REF EBSI1088B; aa) CENTRAL LINE KIT, REF EBSI1245B; bb) CENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc) CVC DRESSING CHANGE KIT, REF EBSI1472A; dd) CVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee) CVL DRESSING CHANGE KIT, REF EBSI1547; ff) DIALYSIS CHANGE KIT, REF EBSI1453; gg) DIALYSIS KIT, REF EBSI1476; hh) DRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii) DRESSING CHANGE TRAY, REF EBSI1513; jj) EBSI DRESSING CHANGE KIT, REF EBSI1163B; kk) ERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll) ERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo) LARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp) OUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq) OUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr) PACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss) PICC DRESSING CHANGE KIT, REF EBSI1471A; tt) PICC DRESSING CHANGE TRAY, REF EBSI1512; uu) PICC DRESSING CHANGE TRAY, REF EBSI1546; vv) PICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww) PICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx) PORT ACCESS TRAY, REF DYNDC2703A; yy) PORT DRESSING CHANGE KIT, REF EBSI1434A; zz) PORT DRESSING CHANGE KIT, REF EBSI1525; aaa) PORT DRESSING CHANGE KIT, REF EBSI1525; bbb) PORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc) SMALL BORE DRESSING CHANGE KIT, REF EBSI1556
Codes / lots: a) REF CVI4705, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23FMD562; b) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers; 23BBJ923, 23CBB549, 23FBM548, 23GBF094, 23GBR827, 23HBM237; c) REF DYNDC3131A, UDI/DI 40195327105694 (case), 10195327105693 (unit), Lot Numbers: 22CBJ619, 22DBD254, 22IBG214; d) DT17405A, UDI/DI 40653160991619 (case), 10653160991618 (unit), Lot Numbers: 22CBY954, 22DBB495, 22DBH244, 22HBT273; e) DT21460B, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; f) DT21460BH, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; g) DM580, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; h) DM580H, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; i) DYNDC3120A, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME583, 23FMC905; j) DYNDC3081, UDI/DI 40193489849746 (case), 10193489849745 (unit), Lot Numbers:…
Reason for recall
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
FDA-determined cause: Nonconforming Material/Component
Action taken
MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-1117-2024
- Initiated
- November 15, 2023
- Posted by FDA
- February 25, 2024
- Product code
- OXQ – Dressing Change Tray
- Quantity
- 86699 units
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1090-2024 Class I | MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1091-2024 Class I | MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as:…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1092-2024 Class I | MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1093-2024 Class I | MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350AMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1094-2024 Class I | MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1095-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1096-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1097-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1098-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1099-2024 Class I | Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1100-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1101-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1102-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1103-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1104-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1105-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1106-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1107-2024 Class I | Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1108-2024 Class I | Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1109-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1110-2024 Class I | Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1111-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1112-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1113-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1114-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1115-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1116-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1118-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1119-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1120-2024 Class I | Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |