Class II

Medical Device Recall: Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYK

MEDLINE INDUSTRIES, LP - Northfield · March 22, 2024

Reason for Recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Product Description

Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, REF DYKM2128; j) KIT,1500CC, 50CS, REF DYKM2126; k) LITHOTOMY, REF DYNJ909937; l) MAJOR BASIC, REF DYNJ909703; m) MINOR GENERAL SURGERY, REF DYNJ909940; n) SUCTION SET UP KIT, REF DYKM1187A; o) TURNOVER KIT, REF DYKC1274A; p) TURNOVER KIT MKT STRAPS, REF DYKC1309A; q) U BAR, REF DYNJ902374K

Distribution

Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

States Affected

NATIONWIDE

Quantity Affected

75098 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2708-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.