Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DY

Summary

The FDA issued a Class II for Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo by MEDLINE INDUSTRIES, LP - Northfield. Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams..

Details

Product Description

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A

Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDH1306, UDI/DI 10889942771523, UDI/DI 40889942771524; b) Model Number DYNDH1389B, UDI/DI 10193489449181, UDI/DI 40193489449182; c) Model Number DYNJ35262A, UDI/DI 10193489903430, UDI/DI 40193489903431; d) Model Number DYNJ39508A, UDI/DI 10889942628919, UDI/DI 40889942628910; e) Model Number DYNJ55954C, UDI/DI 10193489855791, UDI/DI 40193489855792; f) Model Number DYNJ63893, UDI/DI 10193489771565, UDI/DI 40193489771566; g) Model Number DYNJ63893A, UDI/DI 10195327316891, UDI/DI 40195327316892; h) Model Number DYNJ67367, UDI/DI 10193489895711, UDI/DI 40193489895712; i) Model Number DYNJ67381, UDI/DI 10193489896534, UDI/DI 40193489896535; j) Model Number DYNJ68321B, UDI/DI 10195327283346, UDI/DI 40195327283347; k) Model Number DYNJ82250, UDI/DI 10195327181758, UDI/DI 40195327181759; l) Model Number DYNJ84305, UDI/DI 10195327349813, UDI/DI 40195327349814; m) Model Number DYNJ904598B, UDI/DI 10889942946358, UDI/DI 40889942946359; n) Model Number DYNJ905002B, UDI/DI 10195327316860, UDI/DI 40195327316861; o) Model Number DYNJ905004B, UDI/DI 10193489782585, UDI/DI 40193489782586; p) Model Number DYNJ905004C, UDI/DI 10195327316938, UDI/DI 40195327316939; q) Model Number DYNJ908890, UDI/DI 10195327203399, UDI/DI 40195327203390; r) Model Number DYNJ908890A, UDI/DI 10195327259532, UDI/DI 40195327259533; s) Model Number DYNJ908892, UDI/DI 10195327204037, UDI/DI 40195327204038; t) Model Number DYNJ908892A, UDI/DI 10195327259556, UDI/DI 40195327259557;

Quantity Affected: 4398 units

Reason for Recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-05-18

Company