Food, drugs, devices › MEDLINE INDUSTRIES, LP - Northfield
Device recall: Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
FDA enforcement event 95415 is a device recall by MEDLINE INDUSTRIES, LP - Northfield of Northfield, IL, initiated 4 Sep 2024 and classified Class II, with 33 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. MEDLINE INDUSTRIES, LP - Northfield has 120 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
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."
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada, Panama."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0148-2025 | Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit | 30 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0149-2025 | Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit | 90 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0150-2025 | Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY | 168 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0151-2025 | Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit | 30 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0152-2025 | Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit | 15 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0153-2025 | Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A | 320 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0154-2025 | Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B | 312 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0155-2025 | Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) LFT HRT CATH RADIAL ACCESS-LF, REF DYNJ47667C; g) IR… | 1460 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0156-2025 | 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)… | 2631 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0157-2025 | Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PACK-LF, REF DYNJ28487; g) PICC PACK-LF, REF… | 5238 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0158-2025 | Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B; g) BIOPSY TRAY FOAKS, REF DYNJ63575A; h)… | 2,426 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0159-2025 | Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit | 165 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0160-2025 | Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40836F; 7) ENT PACK, REF DYNJ44249J; 8) TONSIL PACK,… | 2740 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0161-2025 | Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK,… | 5972 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0162-2025 | Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit | 1180 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0163-2025 | Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit | 90 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0164-2025 | Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; e) TRAY FOL LATX UM COUD 18FR MF, REF… | 8830 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0165-2025 | Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF DYNJ53205B; g) PLASTIC PACK, REF DYNJ57895; h)… | 1048 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0166-2025 | Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS; 7) TRAY FOL TEMP UM 14FR… | 22,327 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0167-2025 | Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit | 15 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0168-2025 | Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit | 120 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0169-2025 | Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit | 150 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0170-2025 | Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit | 22 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0171-2025 | Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B | 194 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0172-2025 | Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit | 144 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0173-2025 | Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C | 51 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0174-2025 | Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R; 6) LABOR & DELIVERY-LF, REF… | 12,583 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0175-2025 | Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707 | 197 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0176-2025 | Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750 | 88 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0177-2025 | Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PACK, REF DYNJ42884; h) RFT D & C PACK, REF DYNJ50851;… | 1506 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0178-2025 | Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT… | 27,906 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0179-2025 | Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B; 7) FEET,… | 2371 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0180-2025 | Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit | 160 units | Class II | Ongoing | 30 Oct 2024 |
Context
Other enforcement events for MEDLINE INDUSTRIES, LP - Northfield
All 120 events for MEDLINE INDUSTRIES, LP - Northfield
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, Panama."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.