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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;

FDA Recall Z-2317-2023 · Posted 2023-08-03

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeFTN
Date Initiated2023-05-15
Product Quantity11,436 kits

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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