Recall Z-2317-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2317-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-15

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893; d. BREAST PACK, Model Number: DYNDH1306; e. BRST BX TRAY, Model Number: DYNDH1389B; f. CMC BREAST BIOPSY TRAY-LF, Model Number: DYNJ61084A; g. DBD-DIEP PACK, Model Number: DYNJ60669F; h. DBD-FREE FLAP, Model Number: DYNJ907802; i. DBD-FREE FLAP PACK, Model Number: DYNJ83286; j. DBD-MAJOR BREAST, Model Number: DYNJ905004B; k. DBD-PLASTICS FREE FLAP, Model Number: SYNJ910024A; l. DELNOR SIMPLE PLASTIC PACK, Model Number: DYNJ82250; m. DIEP, Model Number: DYNJ905702C, DYNJ905702D; n. DIEP FLAP CDS, Model Number: DYNJ904762D; o. DIEP PACK, Model Number: DYNJ60669C, DYNJ60669D; p. FH BREAST FLAP PACK, Model Number: DYNJ58272C, DYNJ58272D; q. FLAP KIT, Model Number: DYNJ900845B; r. FLAP PACK, Model Number: DYNJ48191G, DYNJ48191I, DYNJ48191J, DYNJ60224B; s. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388P; t. FREE FLAP, Model Number: DYNJ906823A, DYNJ906823B; u. FREE FLAP 1 PACK, Model Number: DYNJ82660; v. FREE FLAP 2 PACK, Model Number: DYNJ82659; w. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320L; x. FREE FLAP CDS, Model Number: CDS983996B; y. FREE FLAP CUSTOM PACK B, Model Number: DYNJ82736; z. FREE FLAP DONOR, Model Number: DYNJ44483B; aa. FREE FLAP PACK, Model Number: DYNJ83286; bb. FREE FLAP PACK-LF, Model Number: DYNJ0271254O, DYNJ20495I, DYNJ42833A, DYNJ42833B, PHS656679003; cc. FREE FLAP RECIPIENT, Model Number: DYNJ44484D, DYNJ44484F; dd. MAIN FLAP, Model Number: DYNJ908264; ee. MAJOR BREAST, Model Number: DYNJ905004A, DYNJ908890; ff. MINOR BREAST, Model Number: DYNJ905002B, DYNJ908892; gg. PK GEN BREAST RESTON, Model Number: DYNJ84305; hh. PLASTIC DIEP PACK, Model Number: DYNJ81727, DYNJ81727A; ii. PLASTIC FREE FLAP, Model Number: DYNJ67367, DYNJ67367A; jj. PLASTIC FREE FLAP PACK, Model Number: DYNJ82758; kk. PLASTIC MICROVASCULAR, Model Number: DYNJ908181, DYNJ908181A, DYNJ908181B; ll. PLASTIC PACK, Model Number: DYNJ35262A; mm. PROCEDURE PACK, Model Number: DYNJ55063; nn. RO-DIEP PACK, Model Number: DYNJ82393; oo. SDS MN BREAST PACK, Model Number: DYNJ57719C, DYNJ57719D; pp. VNUS RFS PROCEDURE PACK, Model Number: DYNJ39508A;. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-05-15
Firm location: Northfield, IL, United States

Product description

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893; d. BREAST PACK, Model Number: DYNDH1306; e. BRST BX TRAY, Model Number: DYNDH1389B; f. CMC BREAST BIOPSY TRAY-LF, Model Number: DYNJ61084A; g. DBD-DIEP PACK, Model Number: DYNJ60669F; h. DBD-FREE FLAP, Model Number: DYNJ907802; i. DBD-FREE FLAP PACK, Model Number: DYNJ83286; j. DBD-MAJOR BREAST, Model Number: DYNJ905004B; k. DBD-PLASTICS FREE FLAP, Model Number: SYNJ910024A; l. DELNOR SIMPLE PLASTIC PACK, Model Number: DYNJ82250; m. DIEP, Model Number: DYNJ905702C, DYNJ905702D; n. DIEP FLAP CDS, Model Number: DYNJ904762D; o. DIEP PACK, Model Number: DYNJ60669C, DYNJ60669D; p. FH BREAST FLAP PACK, Model Number: DYNJ58272C, DYNJ58272D; q. FLAP KIT, Model Number: DYNJ900845B; r. FLAP PACK, Model Number: DYNJ48191G, DYNJ48191I, DYNJ48191J, DYNJ60224B; s. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388P; t. FREE FLAP, Model Number: DYNJ906823A, DYNJ906823B; u. FREE FLAP 1 PACK, Model Number: DYNJ82660; v. FREE FLAP 2 PACK, Model Number: DYNJ82659; w. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320L; x. FREE FLAP CDS, Model Number: CDS983996B; y. FREE FLAP CUSTOM PACK B, Model Number: DYNJ82736; z. FREE FLAP DONOR, Model Number: DYNJ44483B; aa. FREE FLAP PACK, Model Number: DYNJ83286; bb. FREE FLAP PACK-LF, Model Number: DYNJ0271254O, DYNJ20495I, DYNJ42833A, DYNJ42833B, PHS656679003; cc. FREE FLAP RECIPIENT, Model Number: DYNJ44484D, DYNJ44484F; dd. MAIN FLAP, Model Number: DYNJ908264; ee. MAJOR BREAST, Model Number: DYNJ905004A, DYNJ908890; ff. MINOR BREAST, Model Number: DYNJ905002B, DYNJ908892; gg. PK GEN BREAST RESTON, Model Number: DYNJ84305; hh. PLASTIC DIEP PACK, Model Number: DYNJ81727, DYNJ81727A; ii. PLASTIC FREE FLAP, Model Number: DYNJ67367, DYNJ67367A; jj. PLASTIC FREE FLAP PACK, Model Number: DYNJ82758; kk. PLASTIC MICROVASCULAR, Model Number: DYNJ908181, DYNJ908181A, DYNJ908181B; ll. PLASTIC PACK, Model Number: DYNJ35262A; mm. PROCEDURE PACK, Model Number: DYNJ55063; nn. RO-DIEP PACK, Model Number: DYNJ82393; oo. SDS MN BREAST PACK, Model Number: DYNJ57719C, DYNJ57719D; pp. VNUS RFS PROCEDURE PACK, Model Number: DYNJ39508A;

Reason for recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Data sourced from openFDA. This site is unofficial and independent of the FDA.