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Medline Probe Cover Kits containing sterile Ultrasound Gel… recallZ-2166-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 18, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704

Recall details

Recall number
Z-2166-2023
Status
Open, Classified
Initiated by the company
May 18, 2023
Posted by the FDA
Jul 20, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
# included in 3,740,814 units total
Product code
OEZ
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Product description

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;

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

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;

Devices named in this recall

47 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92466).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page