Class II FDA device recall · Z-2166-2023

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.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model Number DYNJ906440A; e) CABG, Model Number DYNJ906878A; f) VALVE, Model Number DYNJ906882A; g) VASCULAR, Model Number DYNJ906883A; h) DR WILLIAMS HEART, Model Number DYNJ907552A; i) PUH PERCUTANEOUS ECMO, Model Number DYNJ907554C; j) TAVR, Model Number DYNJ907561A; k) TAVR, Model Number DYNJ907561B; l) TAVR, Model Number DYNJ907561C; m) OPEN HEART CDS, Model Number DYNJ907607A; n) OPEN HEART CDS, Model Number DYNJ907607B; o) OPEN HEART CDS, Model Number DYNJ907607C; p) OPEN VASCULAR UE, Model Number DYNJ907858A; q) PACEMAKER, Model Number DYNJ907907; r) DEBOER HEART, Model Number DYNJ907914A; s) DEBOER HEART, Model Number DYNJ907914B; t) DEBOER HEART, Model Number DYNJ907914C; u) GENERAL HEART, Model Number DYNJ907915; v) AV FISTULA, Model Number DYNJ907975; w) AV FISTULA, Model Number DYNJ907975A; x) AV FISTULA, Model Number DYNJ907975B; y) SAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B; z) CARDIAC CABG B, Model Number DYNJ908121B; aa) OPEN HEART LINE SET UP, Model Number DYNJ908179A; bb) STEWARD VASCULAR SAS, Model Number DYNJ908563; cc) TAVR, Model Number DYNJ908646; dd) TAVR, Model Number DYNJ908646A; ee) ENDOVASCULAR, Model Number DYNJ908880; ff) ENDOVASCULAR, Model Number DYNJ908880A; gg) VASCULAR, Model Number DYNJ909091; hh) ENDOVASCULAR, Model Number DYNJ909253; ii) TAVR, Model Number DYNJ909270; jj) CABG, Model Number DYNJ9372030G; kk) OPEN HEART, Model Number DYNJ9718008AS; ll) ADULT CORONARY PACK, Model Number DYNJV0275M; mm) RADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A; nn) VASCULAR PACK, Model Number DYNJVB1307; oo) VASCULAR PACK, Model Number DYNJVB1307A; pp) VASCULAR EXTREMITY PPS, Model Number DYNJVB91063C; qq) ENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067; rr) PERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A; ss) VEIN PACK-LF, Model Number PHS151095000; tt) E P PACK-LF, Model Number PHS41732B; uu) PICC VASCULAR ACCESS PACK, Model Number PICCNC0010; vv) TVS4000 ENDOVENOUS PACK, Model Number TVS4000L;

Why it was recalled

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

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 lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Numbers DYNJ906102G, UDI/DI (EA)10195327290795, UDI/DI (CS)40195327290796;  b) Model Numbers DYNJ906102I, UDI/DI (EA)10195327323349, UDI/DI (CS)40195327323340;  c) Model Numbers DYNJ906108C, UDI/DI (EA)10195327118273, UDI/DI (CS)40195327118274;  d) Model Numbers DYNJ906440A, UDI/DI (EA)10193489312874, UDI/DI (CS)40193489312875;  e) Model Numbers DYNJ906878A, UDI/DI (EA)10193489391305, UDI/DI (CS)40193489391306;  f) Model Numbers DYNJ906882A, UDI/DI (EA)10193489391237, UDI/DI (CS)40193489391238;  g) Model Numbers DYNJ906883A, UDI/DI (EA)10193489398205, UDI/DI (CS)40193489398206;  h) Model Numbers DYNJ907552A, UDI/DI (EA)10195327166052, UDI/DI (CS)40195327166053;  i) Model Numbers DYNJ907554C, UDI/DI (EA)10195327183837, UDI/DI (CS)40195327183838;  j) Model Numbers DYNJ907561A, UDI/DI (EA)10195327028848, UDI/DI (CS)40195327028849;  k) Model Numbers DYNJ907561B, UDI/DI (EA)10195327290832, UDI/DI (CS)40195327290833;  l) Model Numbers DYNJ907561C, UDI/DI (EA)10195327323271, UDI/DI (CS)40195327323272;  m) Model Numbers DYNJ907607A, UDI/DI (EA)10193489873405, UDI/DI (CS)40193489873406;  n) Model Numbers DYNJ907607B, UDI/DI (EA)10195327174194, UDI/DI (CS)40195327174195;  o) Model Numbers DYNJ907607C, UDI/DI (EA)10195327335519, UDI/DI (CS)40195327335510;  p) Model Numbers DYNJ907858A, UDI/DI (EA)10195327131357, UDI/DI (CS)40195327131358;  q) Model Numbers DYNJ907907, UDI/DI (EA)10193489939736, UDI/DI (CS)40193489939737;  r) Model Numbers DYNJ907914A, UDI/DI (EA)10195327149529, UDI/DI (CS)40195327149520;  s) Model Numbers DYNJ907914B, UDI/DI (EA)10195327180607, UDI/DI (CS)40195327180608;  t) Model Numbers DYNJ907914C, UDI/DI (EA)10195327329433, UDI/DI (CS)40195327329434;  u) Model Numbers DYNJ907915, UDI/DI (EA)10193489943689, UDI/DI (CS)40193489943680;  v) Model Numbers DYNJ907975, UDI/DI (EA)10193489965605, UDI/DI (CS)40193489965606;  w) Model Numbers DYNJ907975A, UDI/DI (EA)10195327155070, UDI/DI (CS)40195327155071;  x) Model Numbers DYNJ907975B, UDI/DI (EA)10195327376291, UDI/DI (CS)40195327376292;  y) Model Numbers DYNJ908074B, UDI/DI (EA)10195327172688, UDI/DI (CS)40195327172689;  z) Model Numbers DYNJ908121B, UDI/DI (EA)10195327095710, UDI/DI (CS)40195327095711;  aa) Model Numbers DYNJ908179A, UDI/DI (EA)10195327222574, UDI/DI (CS)40195327222575;  bb) Model Numbers DYNJ908563, UDI/DI (EA)10195327086428, UDI/DI (CS)40195327086429;  cc) Model Numbers DYNJ908646, UDI/DI (EA)10195327123956, UDI/DI (CS)40195327123957;  dd) Model Numbers DYNJ908646A, UDI/DI (EA)10195327314965, UDI/DI (CS)40195327314966;  ee) Model Numbers DYNJ908880, UDI/DI (EA)10195327203436, UDI/DI (CS)40195327203437;  ff) Model Numbers DYNJ908880A, UDI/DI (EA)10195327259198, UDI/DI (CS)40195327259199;  gg) Model Numbers DYNJ909091, UDI/DI (EA)10195327268602, UDI/DI (CS)40195327268603;  hh) Model Numbers DYNJ909253, UDI/DI (EA)10195327317027, UDI/DI (CS)40195327317028;  ii) Model Numbers DYNJ909270, UDI/DI (EA)10195327317171, UDI/DI (CS)40195327317172;  jj) Model Numbers DYNJ9372030G, UDI/DI (EA)10195327025434, UDI/DI (CS)40195327025435;  kk) Model Numbers DYNJ9718008AS, UDI/DI (EA)10193489263121, UDI/DI (CS)40193489263122;  ll) Model Numbers DYNJV0275M, UDI/DI (EA)10195327018627, UDI/DI (CS)40195327018628;  mm) Model Numbers DYNJVB1302A, UDI/DI (EA)10193489928341, UDI/DI (CS)40193489928342;  nn) Model Numbers DYNJVB1307, UDI/DI (EA)10193489872910, UDI/DI (CS)40193489872911;  oo) Model Numbers DYNJVB1307A, UDI/DI (EA)10195327227333, UDI/DI (CS)40195327227334;  pp) Model Numbers DYNJVB91063C, UDI/DI (EA)10195327257125, UDI/DI (CS)40195327257126;  qq) Model Numbers DYNJVB91067, UDI/DI (EA)10193489801538, UDI/DI (CS)40193489801539;  rr) Model Numbers PAIN1423A, UDI/DI (EA)10193489201826, UDI/DI (CS)40193489201827;  ss) Model Numbers PHS151095000, UDI/DI (EA)10889942035601, UDI/DI (CS)40889942035602;  tt) Model Numbers PHS41732B, UDI/DI (EA)10193489784817, UDI/DI (CS)40193489784818;  uu) Model Numbers PICCNC0010, UDI/DI (EA)10195327231170, UDI/DI (CS)40195327231171;  vv) Model Numbers TVS4000L, UDI/DI (EA)10195327223540, UDI/DI (CS)40195327223541;

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2166-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-18

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-2166-2023 · Source: openFDA enforcement.