Recall Z-2767-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2767-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-08

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-04-08. It names one FDA 510(k) clearance: K213481. Product: Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 6) BIOPSY TRAY, Pack Number BT1060; 7) BIOPSY TRAY, Pack Number BT1015; 8) BIOPSY TRAY, Pack Number DYNDH1137C; 9) BIOPSY TRAY-LF, Pack Number SPEC4380; 10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 11) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 13) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 14) CIRCUMCISION TRAY, Pack Number CIT7050C; 15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860; 17) ER CHEST TUBE TRAY, Pack Number CHT1570A; 18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406; 21) LUMBAR PUNCTURE TRAY, Pack Number PT215; 22) LUMBAR TRAY, Pack Number SPEC0197B; 23) NICU PICC KIT, Pack Number CVI4575; 24) OB DELIVERY TRAY, Pack Number MNS10875A; 25) ON/OFF KIT, Pack Number DT8525; 26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910; 28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 29) PORT ACCESS KIT, Pack Number DYNDC2945; 30) PORT ACCESS TRAY, Pack Number EBSI1241; 31) PORT INSERTION KIT, Pack Number MNS11590; 32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 33) STEREOTACTIC TRAY, Pack Number MNS5785; 34) SUTURING SET, Pack Number SUT4020; 35) U.A.C. TRAY, Pack Number UVT125; 36) ULTRASOUND TRAY, Pack Number MNS5460; 37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080; 38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A. Reason: 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-04-08
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K213481 — Medline General Surgery TrayMedline Industries, Inc.·cleared 2022-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 6) BIOPSY TRAY, Pack Number BT1060; 7) BIOPSY TRAY, Pack Number BT1015; 8) BIOPSY TRAY, Pack Number DYNDH1137C; 9) BIOPSY TRAY-LF, Pack Number SPEC4380; 10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 11) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 13) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 14) CIRCUMCISION TRAY, Pack Number CIT7050C; 15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860; 17) ER CHEST TUBE TRAY, Pack Number CHT1570A; 18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406; 21) LUMBAR PUNCTURE TRAY, Pack Number PT215; 22) LUMBAR TRAY, Pack Number SPEC0197B; 23) NICU PICC KIT, Pack Number CVI4575; 24) OB DELIVERY TRAY, Pack Number MNS10875A; 25) ON/OFF KIT, Pack Number DT8525; 26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910; 28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 29) PORT ACCESS KIT, Pack Number DYNDC2945; 30) PORT ACCESS TRAY, Pack Number EBSI1241; 31) PORT INSERTION KIT, Pack Number MNS11590; 32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 33) STEREOTACTIC TRAY, Pack Number MNS5785; 34) SUTURING SET, Pack Number SUT4020; 35) U.A.C. TRAY, Pack Number UVT125; 36) ULTRASOUND TRAY, Pack Number MNS5460; 37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080; 38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.