Class II FDA device recall · Z-2320-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126; i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265; j. ENDOVASCULAR PACK, Model Number: DYNJ59085; k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D; l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C; m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B; n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168; o. ENDOVENOUS PACK, Model Number: DYNJ58228; p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443; q. EP LAB, Model Number: DYNJ59392C; r. EP MERCY JANESVILLE, Model Number: DYNJ907013; s. EP PACK, Model Number: DYNJ57594A; t. EVAR, Model Number: DYNJ900005L; u. EVLA PACK, Model Number: DYNJ66258; v. EVLT, Model Number: DYNJ62417, DYNJ64336; w. EVLT CORE PACK, Model Number: DYNJ45294; x. EVLT PACK, Model Number: DYNJ38674A, DYNJ45997C, DYNJ56548B, DYNJ65995, DYNJ65995A, DYNJ66005; y. FEM POP PACK, Model Number: DYNJ01964M, DYNJ67487A; z. FETAL OPEN/EXIT, Model Number: DYNJ904069C; aa. FH THORACIC PACK, Model Number: DYNJ58572B, DYNJ58572C; bb. FISTULAGRAM/C-ACCESS PACK, Model Number: DYNJ59657A; cc. FLAP, Model Number: DYNJ905146A; dd. FREE FLAP PACK CTX, Model Number: DYNJ68380C; ee. FREE FLAP PACK-LF, Model Number: DYNJ0271254P; ff. FREE FLAP TRAM ADD ON PACK, Model Number: DYNJ82179; gg. GEL ULTRASOUND 20G FOIL , Model Number: DYNJZ45357; hh. GENERAL USE PACK, Model Number: DYNJ41137B; ii. GU ROBOTIC PACK-LF, Model Number: DYNJ0972464Y; jj. GYN LITHOTOMY, Model Number: DYNJ906579C; kk. HH VARITHENA VEIN PACK, Model Number: DYNJ59500; ll. HH VEIN CLOSURE PACK, Model Number: DYNJ59501; mm. HH VEIN PICC MADISON PACK, Model Number: DYNJ59508; nn. HILLCREST PCNL PACK, Model Number: DYNJ69204B; oo. HL VEIN STRIPPING PACK, Model Number: DYNJ40374A; pp. HYBRID KIT, Model Number: DYNJ905335; qq. HYBRID OR PACK, Model Number: SYNJ10303B; rr. I.R. PACK, Model Number: DYNJ60343A; ss. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708F; tt. IR MINI KIT, Model Number: DYNJ44519F; uu. IR NEURO PACK, Model Number: DYNJ39198I; vv. IR PERIPHERAL PACK, Model Number: DYNJ45033A; ww. IR SONO PACK, Model Number: DYNDA2365, DYNDA2365B; xx. JBMH EVAR PACK, Model Number: DYNJ69820; yy. JOHNSON OH ACCESSORY PACK, Model Number: DYNJ51927A; zz. JUDKINS PACK-LF, Model Number: DYNJ0530948AR, DYNJ0586030P; aaa. JVL-PACK TUNNELED, Model Number: DYNJ66065; bbb. KF PACK, Model Number: DYNJ57547, DYNJ58647, DYNJ60127A; ccc. KF PACK 2.0, Model Number: DYNJ69619; ddd. KIDNEY CDS, Model Number: DYNJ903873C; eee. KIDNEY TRANSPLANT, Model Number: DYNJ905682; fff. KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173B; ggg. KIT LB OPEN HEART, Model Number: DYNJ902261D, DYNJ904401B; hhh. KT TAVR PACK, Model Number: DYNJ56283B; iii. LARGE PROCEDURE PACK, Model Number: DYNJ35524D; jjj. LASER ABLATION, Model Number: DYNJ80299; kkk. LASER KIT, Model Number: DYNJ64075A; lll. LASER PACK, Model Number: DYNJ39053A; mmm. LINE KIT, Model Number: DYNJ47987B; nnn. LINE PLACEMENT PACK-LF, Model Number: DYNJ0931376F; ooo. LIVER 2018, Model Number: DYNJ905655, DYNJ905655B; ppp. LIVER TRANSPLANT CDS, Model Number: CDS984951D; qqq. LIVER TRANSPLANT PACK, Model Number: DYNJ0271349T; rrr. LONESTAR RF PACK, Model Number: DYNJ83152; sss. MAD PERIPHERAL VASCULAR-LF, Model Number: DYNJ902168D; ttt. MAG FREE FLAP CDS-LF,

Why it was recalled

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

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: DYNJ67517, UPC Number: 019348940782.   b. Model Number: DYNJ51416B, UPC Number: 088827774647.   c. Model Number: DYNJ42913, UPC Number: 088827701320; Model Number: DYNJ42913A, UPC Number: 019532708060.   d. Model Number: DYNJ61243, UPC Number: 019348955091.   e. Model Number: DYNJ66291, UPC Number: 019348932808, Model Number: DYNJ66291A, UPC Number: 019348948000.   f. Model Number: DYNJ57449A, UPC Number: 088994282753.   g. Model Number: DYNJ26940G, UPC Number: 019348954079.   h. Model Number: DYNJ60126, UPC Number: 088994295193.   i. Model Number: DYNJ54265, UPC Number: 088994247400.   j. Model Number: DYNJ59085, UPC Number: 088994293201.   k. Model Number: DYNJ42831D, UPC Number: 088994284953.   l. Model Number: DYNJ53435C, UPC Number: 019348920086.   m. Model Number: DYNJ48456B, UPC Number: 088994273317.   n. Model Number: DYNJ59168, UPC Number: 088827776444.   o. Model Number: DYNJ58228, UPC Number: 088994283549.   p. Model Number: DYNJ62443, UPC Number: 019348967919.   q. Model Number: DYNJ59392C, UPC Number: 019348928224.   r. Model Number: DYNJ907013, UPC Number: 019348931863.   s. Model Number: DYNJ57594A, UPC Number: 088994296321.   t. Model Number: DYNJ900005L, UPC Number: 019348930031.   u. Model Number: DYNJ66258, UPC Number: 019348932547.   v. Model Number: DYNJ62417, UPC Number: 019348965705; Model Number: DYNJ64336, UPC Number: 019348980187.   w. Model Number: DYNJ45294, UPC Number: 088827709897.   x. Model Number: DYNJ38674A, UPC Number: 019348956435; Model Number: DYNJ45997C, UPC Number: 088994268436; Model Number: DYNJ56548B, UPC Number: 019348981318; Model Number: DYNJ65995, UPC Number: 019348931154; Model Number: DYNJ65995A, UPC Number: 019532706812; Model Number: DYNJ66005, UPC Number: 019348931254.   y. Model Number: DYNJ01964M, UPC Number: 019348956435; Model Number: DYNJ67487A, UPC Number: 019348988899.   z. Model Number: DYNJ904069C, UPC Number: 019348999549.   aa. Model Number: DYNJ58572B, UPC Number: 019348989338; Model Number: DYNJ58572C, UPC Number: 019532714262.   bb. Model Number: DYNJ59657A, UPC Number: 019348954461.   cc. Model Number: DYNJ905146A, UPC Number: 019348956922.   dd. Model Number: DYNJ68380C, UPC Number: 019532734124.   ee. Model Number: DYNJ0271254P, UPC Number: 019532708953.   ff. Model Number: DYNJ82179, UPC Number: 019532718266.   gg. Model Number: DYNJZ45357, UPC Number: 088994237354.   hh. Model Number: DYNJ41137B, UPC Number: 088994226087.    ii. Model Number: DYNJ0972464Y, UPC Number: 019348978326.   jj. Model Number: DYNJ906579C, UPC Number: 019532702356.   kk. Model Number: DYNJ59500, UPC Number: 088827775013.   ll. Model Number: DYNJ59501, UPC Number: 088827775014.   mm. Model Number: DYNJ59508, UPC Number: 088827775130.   nn. Model Number: DYNJ69204B, UPC Number: 019532736422.   oo. Model Number: DYNJ40374A, UPC Number: 088827755794.   pp. Model Number: DYNJ905335, UPC Number: 088994287589.   qq. Model Number: SYNJ10303B, UPC Number: 019348937374.   rr. Model Number: DYNJ60343A, UPC Number: 019348957383.   ss. Model Number: DYNJ9048708F, UPC Number: 019348972521.   tt. Model Number: DYNJ44519F, UPC Number: 019348946747.   uu. Model Number: DYNJ39198I, UPC Number: 019348956435.   vv. Model Number: DYNJ45033A, UPC Number: 019348947580.   ww. Model Number: DYNDA2365, UPC Number: 019348951634; Model Number: DYNDA2365B, UPC Number: 019348983644.   xx. Model Number: DYNJ69820, UPC Number: 019348998143.   yy. Model Number: DYNJ51927A, UPC Number: 088827779416.   zz. Model Number: DYNJ0530948AR, UPC Number: 019532714188; Model Number: DYNJ0586030P, UPC Number: 088994294714.   aaa. Model Number: DYNJ66065, UPC Number: 019348931918.   bbb. Model Number: DYNJ57547, UPC Number: 088994275104; Model Number: DYNJ58647, UPC Number: 088994287545; Model Number: DYNJ60127A, UPC Number: 019348972904.   ccc. Model Number: DYNJ69619, UPC Number: 019348995944.   ddd. Model Number: DYNJ903873C, UPC Number: 019348946309.   eee. Model Number: DYNJ905682, UPC Number: 088827779190.   fff. Model Number: DYKMBNDL173B, UPC Number: 019532724075.   ggg. Model Number: DYNJ902261D, UPC Number: 088994275524; Model Number: DYNJ904401B, UPC Number: 019348968343.   hhh. Model Number: DYNJ56283B, UPC Number: 019348969525.   iii. Model Number: DYNJ35524D, UPC Number: 019348976610.   jjj. Model Number: DYNJ80299, UPC Number: 019532702193.   kkk. Model Number: DYNJ64075A, UPC Number: 019348923132.   lll. Model Number: DYNJ39053A, UPC Number: 019348956435.   mmm. Model Number: DYNJ47987B, UPC Number: 019348986737.   nnn. Model Number: DYNJ0931376F, UPC Number: 019348927150.   ooo. Model Number: DYNJ905655, UPC Number: 088827778885; Model Number: DYNJ905655B, UPC Number: 019532713015.   ppp. Model Number: CDS984951D, UPC Number: 019348925779.   qqq. Model Number: DYNJ0271349T, UPC Number: 019532708969.   rrr. Model Number: DYNJ83152, UPC Number: 019532723708.   sss. Model Number: DYNJ902168D, UPC Number: 019348986615.   ttt. Model Number: CDS982911M, UPC Number: 019348946493.   uuu. Model Number: DYNJ68172, UPC Number: 019348949239.   vvv. Model Number: CDS980752I, UPC Number: 088994242854; Model Number: DYNJ54285A, UPC Number: 088994276548.   www. Model Number: CDS983315G, UPC Number: 088994286443.   xxx. Model Number: DYND2673B, UPC Number: 019348956435.   yyy. Model Number: DYNJ51705B, UPC Number: 019348987717.   zzz. Model Number: DYNJ0248546C, UPC Number: 088994205551; Model Number: DYNJ0248546D, UPC Number: 019532706928.   aaaa. Model Number: CDS984379D, UPC Number: 088994272434.   bbbb. Model Number: MID0001, UPC Number: 019348938162.   cccc. Model Number: DYNJ80141MB, UPC Number: 088994273341.   dddd. Model Number: PICC0009A, UPC Number: 088994214185.   eeee. Model Number: DYNJ80152MB, UPC Number: 088994273342.   ffff. Model Number: DYNJ905002A, UPC Number: 088994291165.   gggg. Model Number: DYNJ64439, UPC Number: 019348920048.   hhhh. Model Number: DYNJ38326F, UPC Number: 019348956435.   iiii. Model Number: DYNJ902281, UPC Number: 088827798141.   jjjj. Model Number: NG410A, UPC Number: 088994294588.   kkkk. Model Number: DYNJ63892, UPC Number: 019348977143.   llll. Model Number: DYNJ69716A, UPC Number: 019532725057.   mmmm. Model Number: ARTNC115, UPC Number: 065316035433.   nnnn. Model Number: DYNJ63739, UPC Number: 019348975467.   oooo. Model Number: DYNJ59201B, UPC Number: 019348931026; Model Number: DYNJ59201C, UPC Number: 019532706202.   pppp. Model Number: DYNJ908680, UPC Number: 019532713938.   qqqq. Model Number: DYNJ61517, UPC Number: 019348957757.   rrrr. Model Number: DYNJ82561, UPC Number: 019532719797.   ssss. Model Number: DYNJ54569A, UPC Number: 019348974295.   tttt. Model Number: DYNJ60126A, UPC Number: 019348924708.   uuuu. Model Number: DYNJ65488B, UPC Number: 019348944364.   vvvv. Model Number: DYNJ906902, UPC Number: 019348928093.   wwww. Model Number: DYNJ906895C, UPC Number: 019532730355.   xxxx. Model Number: DYNDH1165A, UPC Number: 088994261150, 10889942611508.   yyyy. Model Number: DYNJ37280C, UPC Number: 088994243165; Model Number: DYNJ56536, UPC Number: 088994265471.   zzzz. Model Number: DYNDH1292, UPC Number: 088994274223; Model Number: DYNDH1470B, UPC Number: 019348911124; Model Number: DYNDH1470C, UPC Number: 019532729771.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2320-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-15

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2320-2023 · Source: openFDA enforcement.