Class II FDA device recall · Z-2300-2023

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. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d. ABLATION PACK, Model Number: DYNJ61957A; e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F; f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M; g. AFIB PACK, Model Number: DYNJ69682; h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F; i. ANGIO-VASCULAR, Model Number: DYNJ24272C; j. ARM VASCULAR-LF, Model Number: DYNJ905290D; k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038; l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A; m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051; n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D; o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C; p. AV FIST PACK, Model Number: DYNJ83462; q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096; r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570; s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477; t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C; u. AV FISTULA VASCULAR, Model Number: DYNJ67340; v. AV GRAFT, Model Number: DYNJ903457D; w. AV GRAFT-LF, Model Number: DYNJ40077F; x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I; y. BEDSIDE PICC CDS, Model Number: CDS984642; z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339; aa. C V MAJOR PACK, Model Number: DYNJ64861A; bb. C V MINOR PACK, Model Number: DYNJ64862B; cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G; dd. CABG HEART CDS, Model Number: CDS985384C; ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F; ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A; gg. CARDIAC A B PACK-LF, Model Number: DYNJV0177AG; hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG; ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B; jj. CARDIAC CABG PACK, Model Number: DYNJ903072R; kk. CARDIAC CATH PACK, Model Number: DYNJ41195D; ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M; mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A; nn. CARDIOLOGY EP, Model Number: DYNJ59968; oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F; pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D; qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A; rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A; ss. CAROTID PACK-LF, Model Number: DYNJ57646C; tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369; uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F; vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K; ww. CATH LAB PACK, Model Number: DYNJ57735F; xx. CATH PACK, Model Number: DYNJ59830A; yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A; zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G; aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I; bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A; ddd. CV CDS, Model Number: CDS985395D; eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432; fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A; ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D; hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C; iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; kkk. DBD-AV FISTUL

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: DYNJ44847I, UPC Number: 019532712755.  b. Model Number: DYNJ82578, UPC Number: 019532719814.  c. Model Number: DYNJ905291B, UPC Number: 019348995037; Model Number: DYNJ905291C, UPC Number: 019532706254.  d. Model Number: DYNJ61957A, UPC Number: 019348969907.  e. Model Number: DYNJ36600F, UPC Number: 088994255256.   f. Model Number: DYNJV0275J, UPC Number: 019348926312; Model Number: DYNJV0275K, UPC Number: 019348926312; Model Number: DYNJV0275L, UPC Number: 019348926312; Model Number: DYNJV0275M, UPC Number: 019532701862.   g. Model Number: DYNJ69682, UPC Number: 019348996892.  h. Model Number: CDS840493F, UPC Number: 019348964363.  i. Model Number: DYNJ24272C, UPC Number: 019348962022.   j. Model Number: DYNJ905290D, UPC Number: 019532706253.  k. Model Number: DYNDC3038, UPC Number: 019348949360.  l. Model Number: DYNJ81636, UPC Number: 019532712918; Model Number: DYNJ81636A, UPC Number: 019532724491.  m. Model Number: DYNJ83051, UPC Number: 019532724528.  n. Model Number: DYNJ40728D, UPC Number: 019532734836.   o. Model Number: DYNJ40728A, UPC Number: 088827704690; Model Number: DYNJ40728B, UPC Number: 019348997028; Model Number: DYNJ40728C, UPC Number: 019532703746.   p. Model Number: DYNJ83462, UPC Number: 019532726814.  q. Model Number: DYNJ64143B, UPC Number: 019532727958; Model Number: DYNJ905219B, UPC Number: 019348992403; Model Number: DYNJ905219C, UPC Number: 019532712693; Model Number: DYNJ905219D, UPC Number: 019532715487; Model Number: DYNJ905219F, UPC Number: 019532733532; Model Number: DYNJ906341D, UPC Number: 019532702148; Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975, UPC Number:019348996560; Model Number: DYNJ907975B, UPC Number: 019532737629; Model Number: DYNJ908096, UPC Number: 019348997407.  r. Model Number: DYNJ82570, UPC Number: 019532719806.  s. Model Number: DYNJ52093J, UPC Number: 019348998856; Model Number: DYNJ62218B, UPC Number: 019348996016; Model Number: DYNJ66184A, UPC Number: 019348991193; Model Number: DYNJ66184B, UPC Number: 019532703433; Model Number: DYNJ67178A, UPC Number: 019532702787; Model Number: DYNJ69443A, UPC Number: 019532702654; Model Number: DYNJ69443B, UPC Number: 019532708906; Model Number: DYNJ69443D, UPC Number: 019532727023; Model Number: DYNJ69489A, UPC Number: 019532722704; Model Number: DYNJ81033, UPC Number: 019532708298; Model Number: DYNJ81605, UPC Number: 019532712388; Model Number: DYNJ82477, UPC Number: 019532719722.  t. Model Number: DYNJ64499B, UPC Number: 019348996109; Model Number: DYNJ64499, UPC Number: 019532722644; Model Number: DYNJ69167A, UPC Number: 019532708351; Model Number: DYNJ69167C, UPC Number: 019532734312.  u. Model Number: DYNJ67340, UPC Number: 019348990107.  v. Model Number: DYNJ903457D, UPC Number: 019348967091.  w.  Model Number: DYNJ40077F, UPC Number: 019532717581.  x. Model Number: CDS983147F, UPC Number: 019348963379; Model Number: CDS983147I, UPC Number: 019532707551.  y. Model Number: CDS984642, UPC Number: 088438988292.  z. Model Number: DYNJ907339, UPC Number: 019348939732.  aa. Model Number: DYNJ64861A, UPC Number: 019532705363.  bb.  Model Number: DYNJ64862B, UPC Number: 019532705370.  cc. Model Number: DYNJ906878A, UPC Number: 019348939130; Model Number: DYNJ9372030F, UPC Number: 019348966807; Model Number: DYNJ9372030G, UPC Number: 019532702543.  dd. Model Number: CDS985384C, UPC Number: 088994296218.  ee. Model Number: DYNJ0408782AA, UPC Number: 019532711581; Model Number: DYNJ53827, UPC Number: 088994244401; Model Number: DYNJ59036B, UPC Number: 019348967227; Model Number: DYNJ59036C, UPC Number: 019348988162; Model Number: DYNJ59036D, UPC Number: 019532700347; Model Number: DYNJ59036F, UPC Number: 019532727293.  ff. Model Number: DYNJ68389, UPC Number: 019348944114; Model Number: DYNJ68389A, UPC Number: 019348991219.  gg. Model Number: DYNJV0177AG, UPC Number: 019532711235.  hh. Model Number: DYNJV0177AG, UPC Number: 019532711235.   ii. Model Number: DYNJ908121A, UPC Number: 019532700057; Model Number: DYNJ908121B, UPC Number: 019532709571.   jj. Model Number: DYNJ903072R, UPC Number: 019348983405.  kk. Model Number: DYNJ41195D, UPC Number: 019348931425.  ll. Model Number: DYNJ0429185K, UPC Number: 019348956435; Model Number: DYNJ0429185M, UPC Number: 019532737135.  mm. Model Number: DYNJ66254A, UPC Number: 019348981897.  nn. Model Number: DYNJ59968, UPC Number: 088827779132.  oo. Model Number: DYNJ905516C, UPC Number: 019348996712; Model Number: DYNJ905516D, UPC Number: 019532714783; Model Number: DYNJ905516F, UPC Number: 019532724757.  pp. Model Number: DYNJ906351B, UPC Number: 019348981671; Model Number: DYNJ906351D, UPC Number: 019532716157.  qq. Model Number: DYNJ905640A, UPC Number: 019532703918.  rr. Model Number: DYNJ0810062AI, UPC Number: 019348956435; Model Number: DYNJ0810062AJ, UPC Number: 019532732546; Model Number: DYNJ39488G, UPC Number: 019348938377; Model Number: DYNJ66190A, UPC Number: 019348991300; Model Number: DYNJ66190B, UPC Number: 019532703432; Model Number: DYNJ66190C, UPC Number: 019532734200; Model Number: DYNJ80346A, UPC Number: 019532716625.  ss. Model Number: DYNJ57646C, UPC Number: 019532728713.   tt. Model Number: DYNJ81369, UPC Number: 019532711530.  uu. Model Number: DYNJ44927F, UPC Number: 019348976680.  vv. Model Number: CDS984764F, UPC Number: 088994296945; Model Number: DYNJ901745K, UPC Number: 019348948223.  ww. Model Number: DYNJ57735F, UPC Number: 019348962970.  xx. Model Number: DYNJ59830A, UPC Number: 019348957023.  yy. Model Number: DYNJ62379A, UPC Number: 019532719663.  zz. Model Number: DYNJC9258G, UPC Number: 019532724550.  aaa. Model Number: CDS983202F, UPC Number: 019348933525; Model Number: CDS983202G, UPC Number: 019348949077; Model Number: CDS983202I, UPC Number: 019532716467.  bbb. Model Number: DYNJ906108A, UPC Number: 019348944363; Model Number: DYNJ906108B, UPC Number: 019532704117; Model Number: DYNJ906108C, UPC Number: 019532711827.  ccc. Model Number: DYNJ65710A, UPC Number: 019348993865.  ddd. Model Number: CDS985395D, UPC Number: 019348985971.  eee. Model Number: DYNJ83432, UPC Number: 019532726653.  fff. Model Number: DYNJ64506A, UPC Number: 019348997106.  ggg. Model Number: DYNJ46359C, UPC Number: 088994253711; Model Number: DYNJ46359D, UPC Number: 019348996137.  hhh.  Model Number: DYNJ905291C, UPC Number: 019532706254.  iii. Model Number: CDS840493F, UPC Number: 019348964363.  jjj. Model Number: CDS840493F, UPC Number: 019348964363.   kkk. Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975A, UPC Number: 019532715507.  lll. Model Number: DYNJ69443C, UPC Number: 019532712973.  mmm. Model Number: DYNJ57646B, UPC Number: 019348982850.  nnn. Model Number: DYNJ64964B, UPC Number: 019532707581.  ooo. Model Number: DYNJ59028A, UPC Number: 019348973659.  ppp. Model Number: DYNJ907552A, UPC Number: 019532716605.  qqq. Model Number: DYNJ56904, UPC Number: 088994269345.  rrr. Model Number: DYNJ63209, UPC Number: 019348972788.    sss. Model Number: DYNJ67487B, UPC Number: 019532716614.  ttt. Model Number: DYNJ905495F, UPC Number: 019348992493.  uuu. Model Number: DYKMBNDL22B, UPC Number: 019532705026.  vvv. Model Number: DYNJ905884A, UPC Number: 019348979544.  www. Model Number: DYNJ81610, UPC Number: 019532712394.  xxx. Model Number: DYNJ54286A, UPC Number: 088994276549.  yyy. Model Number: CDS984241M, UPC Number: 019532716563.  zzz. Model Number: DYNJ23697N, UPC Number: 019348949845.  aaaa. Model Number: DYNJ55836B, UPC Number: 019348995117.   bbbb. Model Number: DYNJ63341C, UPC Number: 019532708612.   cccc. Model Number: DYNJ48365, UPC Number: 088827759459.   dddd. Model Number: DYNJ69422, UPC Number: 019348993754.   eeee. Model Number: DYNJ905744C, UPC Number: 019532716231.   ffff. Model Number: CDS984764G, UPC Number: 019348945029.   gggg. Model Number: DYNJ81642, UPC Number: 019532712966.   hhhh. Model Number: DYNJ68404A, UPC Number: 019348991392.   iiii. Model Number: DYNJ65048, UPC Number: 019348924286.   jjjj. Model Number: DYNJ43085A, UPC Number: 019348960034.   kkkk. Model Number: DYNJ64261A, UPC Number: 019348932556.   llll. Model Number: DYNJ42976, UPC Number: 088827701914.   mmmm. Model Number: DYNJ907914, UPC Number: 019348994367; Model Number: DYNJ907914A, UPC Number: 019532714952; Model Number: DYNJ907914B, UPC Number: 019532718060; Model Number: DYNJ907914C, UPC Number: 019532732943.   nnnn. Model Number: DYNJ57595A, UPC Number: 019348962215.   oooo. Model Number: DYNJ0037939B, UPC Number: 019532703127.   pppp. Model Number: DYNJ52024, UPC Number: 088994223335.   qqqq. Model Number: DYNJ51968D, UPC Number: 019348967831.   rrrr. Model Number: DYNJ56235, UPC Number: 088994262155.   ssss. Model Number: DYNJ61247, UPC Number: 019348955170.   tttt. Model Number: DYNJ907552A, UPC Number: 019532716605.   uuuu. Model Number: DYNJ67517A, UPC Number: 019348946219.   vvvv. Model Number: PHS41732B, UPC Number: 019348978481.   wwww. Model Number: DYNJ55669C, UPC Number: 019348944785; Model Number: DYNJ55669D, UPC Number: 019532701301.   xxxx. Model Number: DYNJ57449C, UPC Number: 019348947184; Model Number: DYNJ57449D, UPC Number: 019348987229; Model Number: DYNJ57449F, UPC Number: 019348993920; Model Number: DYNJ57449G, UPC Number: 019532706488.   yyyy. Model Number: DYNJ49931I, UPC Number: 019348993921.   zzzz. Model Number: DYNJ54803B, UPC Number: 019348963378; Model Number: DYNJ54803C, UPC Number: 019348920261.

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-2300-2023
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-2300-2023 · Source: openFDA enforcement.