Recall record at a glance
| Official record | Z-2312-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Aug 9, 2023 |
| Recall initiation date | May 15, 2023 |
| Quantity | 16,143 kits |
| Location | Northfield, IL, United States |
Official product description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O; e. BARIATRIC PACK, Model Number: DYNJ24459P; f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242; g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942; h. DBD-FETOSCOPIC, Model Number: DYNJ905761A; i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B; j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A; k. DIEP, Model Number: DYNJ901296B; l. DIEP FLAP, Model Number: DYNJ66867A; m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N; n. ECMO PACK, Model Number: DYNJ82517; o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B; p. ENDOVASCULAR, Model Number: DYNJ63343G; q. EVLT SURGICAL PACK, Model Number: DYNJ48520; r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q; s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C; t. FLAP HARVEST PACK, Model Number: DYNJ58575B; u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O; v. FREE FLAP, Model Number: DYNJ905634B; w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290; x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K; y. FREE FLAP BASIN PACK, Model Number: DYNJ69914; z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A; aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B; bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K; cc. GENERAL ANGIO PACK, Model Number: DYNJ57760; dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M; ee. HILLCREST PCNL PACK, Model Number: DYNJ69204; ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B; gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; hh. LAP CHOLE PACK, Model Number: DYNJ41208D; ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B; jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A; kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A; ll. MINOR, Model Number: DYNJ906915; mm. MINOR CV, Model Number: DYNJ69898A; nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A; pp. PCNL PACK, Model Number: DYNJ0569950Q; qq. PLANO DIEP PACK, Model Number: DYNJ81751; rr. PORT PACK, Model Number: DYNJ61747C; ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C; tt. PV MINOR PACK, Model Number: DYNJ63879D; uu. RF PACK, Model Number: DYNJ52505A; vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C; ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F; xx. ROBOTIC-LF, Model Number: DYNJ904254F; yy. ROBOTICS GYN, Model Number: DYNJ905824D; zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A; aaa. TAA AAA, Model Number: DYNJ63339C; bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B; ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D;
Why the product was recalled
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution information
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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