FDA Enforcement Class II Ongoing

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 · Reported August 9, 2023

Enforcement

Recall Number: Z-2317-2023
Event ID: 92399
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: MEDLINE INDUSTRIES, LP - Northfield
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: August 9, 2023
Initiation Date: May 15, 2023
Classification Date: August 3, 2023
Address: 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

Description

Reason

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

Code Info

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ909031, UPC Number: 019532725061. b. Model Number: DYNJ904598B, UPC Number: 088994294635. c. Model Number: DYNJ63893, UPC Number: 019348977156. d. Model Number: DYNDH1306, UPC Number: 088994277152. e. Model Number: DYNDH1389B, UPC Number: 019348944918. f. Model Number: DYNJ61084A, UPC Number: 019348969202. g. Model Number: DYNJ60669F, UPC Number: 019532728956. h. Model Number: DYNJ907802, UPC Number: 019348989000. i. Model Number: DYNJ83286, UPC Number: 019532725665. j. Model Number: DYNJ905004B, UPC Number: 019348978258. k. Model Number: SYNJ910024A, UPC Number: 019348937448. l. Model Number: DYNJ82250, UPC Number: 019532718175. m. Model Number: DYNJ905702C, UPC Number: 019532700467; Model Number: DYNJ905702D, UPC Number: 019532717382. n. Model Number: DYNJ904762D, UPC Number: 019532725881. o. Model Number: DYNJ60669C, UPC Number: 019532702362; Model Number: DYNJ60669D, UPC Number: 019532721717. p. Model Number: DYNJ58272C, UPC Number: 019348989552; Model Number: DYNJ58272D, UPC Number: 019532714511. q. Model Number: DYNJ900845B, UPC Number: 088994263442. r. Model Number: DYNJ48191G, UPC Number: 019348947660; Model Number: DYNJ48191I, UPC Number: 019532705781; Model Number: DYNJ48191J, UPC Number: 019532725503; Model Number: DYNJ60224B, UPC Number: 019348987735. s. Model Number: DYNJ0378388P, UPC Number: 019532708997. t. Model Number: DYNJ906823A, UPC Number: 019348989447; Model Number: DYNJ906823B, UPC Number: 019532702707. u. Model Number: DYNJ82660, UPC Number: 019532719933. v. Model Number: DYNJ82659, UPC Number: 019532719932. w. Model Number: DYNJ0991320L, UPC Number: 019532702854. x. Model Number: CDS983996B, UPC Number: 088994213130. y. Model Number: DYNJ82736, UPC Number: 019532720755. z. Model Number: DYNJ44483B, UPC Number: 088994281894. aa. Model Number: DYNJ83286, UPC Number: 019532725665. bb. Model Number: DYNJ0271254O, UPC Number: 019348956435; Model Number: DYNJ20495I, UPC Number: 019348956435; Model Number: DYNJ42833A, UPC Number: 088827750399; Model Number: DYNJ42833B, UPC Number: 019348988033; Model Number: PHS656679003, UPC Number: 088994204000. cc. Model Number: DYNJ44484D, UPC Number: 088994281895; Model Number: DYNJ44484F, UPC Number: 019348948834. dd. Model Number: DYNJ908264, UPC Number: 019532702011. ee. Model Number: DYNJ905004A, UPC Number: 088994291171, Model Number: DYNJ908890, UPC Number: 019532720339. ff. Model Number: DYNJ905002B, UPC Number: 019532731686, Model Number: DYNJ908892, UPC Number: 019532720403. gg. Model Number: DYNJ84305, UPC Number: 019532734981. hh. Model Number: DYNJ81727, UPC Number: 019532713711; Model Number: DYNJ81727A, UPC Number: 019532727789. ii. Model Number: DYNJ67367, UPC Number: 019348989571; Model Number: DYNJ67367A, UPC Number: 019532723070. jj. Model Number: DYNJ82758, UPC Number: 019532720744. kk. Model Number: DYNJ908181, UPC Number: 019532700174; Model Number: DYNJ908181A, UPC Number: 019532706226; Model Number: DYNJ908181B, UPC Number: 019532724293. ll. Model Number: DYNJ35262A, UPC Number: 019348990343. mm. Model Number: DYNJ55063, UPC Number: 088994252657. nn. Model Number: DYNJ82393, UPC Number: 019532718973. oo. Model Number: DYNJ57719C, UPC Number: 019348976734; Model Number: DYNJ57719D, UPC Number: 019348994582. pp. Model Number: DYNJ39508A, UPC Number: 088994262891.

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