BEUDAMED
    FDA Recall Open, Classified

    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;

    Recall: Z-2317-2023 · Initiated May 15, 2023

    Recall

    Recall Number
    Z-2317-2023
    Event Number
    92399
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    FTN
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 15, 2023
    Posted
    August 3, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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

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

    Action

    Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

    Quantity

    11,436 kits