Medline Industries, LP: Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003

Company / brand

Medline Industries, LP

Product

Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003

Reason / hazard

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Classification

Class II

Status

Ongoing

Distribution / sold at

Worldwide distribution - US Nationwide.

Recall initiated

2026-01-07

Code info

1) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24EMC989; 2) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059A; 3) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059; 4) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24BBH600; 5) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23JBH393; 6) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23GBA134; 7) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBV199; 8) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBT510; 9) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBN951; 10) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23BBS986; 11) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23ABA768; 12) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 22JBH446

Product quantity

2236 units

Voluntary mandated

Voluntary: Firm initiated

City

Northfield

State

IL

Country

United States

Event id

98329

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