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FDA (Device enforcement)Recalled 2025-03-03class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Mode

Hazard

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Details from the source

Reason for recall: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands. Quantity: 573 units Lot/code info: 1) DYNJ84880, UDI-DI: 10195327432140(each), 40195327432141(case), Lot Number: 24JBL926; 2) DYNJ56229A, UDI-DI: 10198459108105(each), 40198459108106(case), Lot Number: 24JBV124; 3) PHS807626F, UDI-DI: 10198459028045(each), 40198459028046(case), Lot Number: 24JBV611; 4) DYNJ41929D, UDI-DI: 10198459160585(each), 40198459160586(case), Lot Number: 24JBW877; 5) DYNJ51841C, UDI-DI: 10195327522186(each), 40195327522187(case), Lot Number: 24KBA623; 6) DYNJ905551C, UDI-DI: 10195327556099(each), 40195327556090(case), Lot Number: 24KBN091

UPC codes

10195327432140, 40195327432141, 10198459108105, 40198459108106, 10198459028045, 40198459028046, 10198459160585, 40198459160586, 10195327522186, 40195327522187, 10195327556099, 40195327556090

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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