Recall Z-1103-2024— MEDLINE INDUSTRIES, LP - Northfield
Class I · Ongoing
Class I FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-11-15. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE TRAY, REF SUT13535; j) SNES ENDO KIT, REF DYKE1930A. Reason: 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..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-11-15
- Firm location
- Northfield, IL, United States
Product description
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE TRAY, REF SUT13535; j) SNES ENDO KIT, REF DYKE1930A
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.