Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIA...
FDA Device Recall #Z-2167-2023 — Class II — May 18, 2023
Recall Summary
| Recall Number | Z-2167-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 18, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 269985 units |
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number CVI4805; e) ED CENTRAL LINE KIT, Model Number CVI4865; f) NO CATH MIDLINE INSERTION KIT, Model Number CVI4950A; g) CENTRAL LINE PROCEDURE KIT, Model Number DT22260; h) ADULT EPIV INSERTION TRAY, Model Number DYNDA2482; i) ULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669; j) I.R. PICC PACK, Model Number DYNDA2759; k) IR SONO PACK, Model Number DYNDA3010; l) NEONATAL PICC LINE TRAY, Model Number DYNDC2120B; m) PICC SUPPLEMENTAL KIT, Model Number DYNDC2373A; n) CENTRAL LINE KIT, Model Number DYNDC2582A; o) CENTRAL LINE KIT UTMB, Model Number DYNDC3061; p) FNA TRAY, Model Number DYNDH1123B; q) CVL PACK, Model Number DYNJ00281O; r) CENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O; s) CENTRAL LINE PACK-LF, Model Number DYNJ0220136Q; t) PICC LINE PACK-LF, Model Number DYNJ0235859I; u) PICC LINE PACK-LF, Model Number DYNJ0235859J; v) PICC LINE PACK-LF, Model Number DYNJ0235859K; w) PICC LINE PACK, Model Number DYNJ04592K; x) PICC LINE PACK-LF, Model Number DYNJ0678523N; y) PICC LINE PACK-LF, Model Number DYNJ0855123N; z) PICC INSERTION PACK-LF, Model Number DYNJ0880659F; aa) PICC PACK-LF, Model Number DYNJ0940720D; bb) VENOUS ACCESS PACK-LF, Model Number DYNJ09895R; cc) PICC PACK-LF, Model Number DYNJ17086A; dd) VENOUS ACCESS TRAY, Model Number DYNJ20094L; ee) PICC LINE PACK-LF, Model Number DYNJ21575I; ff) CENTRAL LINE PACK, Model Number DYNJ30087C; gg) PICC LINE PACK, Model Number DYNJ30233C; hh) PICC PACK, Model Number DYNJ30566B; ii) CENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G; jj) PICC TRAY, Model Number DYNJ33005F; kk) PICC TRAY, Model Number DYNJ33005G; ll) PICC LINE INSERTION TRAY, Model Number DYNJ34241; mm) PICC PACK-LF, Model Number DYNJ35000I; nn) PORT PACK, Model Number DYNJ35163C; oo) PICC TRAY-LF, Model Number DYNJ35272; pp) PICC LINE INSERTION PACK, Model Number DYNJ38868K; qq) PICC LINE INSERTION PACK, Model Number DYNJ38868L; rr) PICC ACCESSORY TRAY, Model Number DYNJ39039M; ss) CVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B; tt) PICC INSERTION PACK MH-LF, Model Number DYNJ40206B; uu) ACCESS PICC PACK, Model Number DYNJ40682B; vv) PHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C; ww) MV-IR-PICC PACK-LF, Model Number DYNJ41554C; xx) PICC TRAY, Model Number DYNJ41648; yy) CENTRAL LINE TRAY, Model Number DYNJ42902C; zz) CENTRAL LINE TRAY, Model Number DYNJ42902D; aaa) VENOUS PACK, Model Number DYNJ43168; bbb) VENOUS PACK, Model Number DYNJ43168A; ccc) VENOUS PACK, Model Number DYNJ43168B; ddd) IR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G; eee) WEST VALLEY PICC LINE PACK, Model Number DYNJ43975A; fff) VENOUS LIGATION PACK, Model Number DYNJ43981G; ggg) VEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C; hhh) VENOUS ABLATION, Model Number DYNJ44904C; iii) PICC LINE PACK, Model Number DYNJ47037C; jjj) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B; kkk) CENTRAL LINE PACK, Model Number DYNJ48096B; lll) PICC PACK-LF, Model Number DYNJ48120B; mmm) AV FISTULA PACK-LF, Model Number DYNJ48428C; nnn) VIEN CLOSURE, Model Number DYNJ49180A; ooo) ARTERIAL LINE PACK, Model Number DYNJ49235D; ppp) PICC PACK, Model Number DYNJ52255; qqq) PICC LINE TRAY, Model Number DYNJ52688B; rrr) PICC LINE TRAY, Model Number DYNJ52688C; sss) CENTRAL LINE INSERTION KIT, Model Number DYNJ52894A; ttt) ARTERIOGRAM PACK, Model Number DYNJ53095A; uuu) ENDOVENOUS ABLATION PACK, Model Number DYNJ53435D; vvv) MID HUDSON PICC LINE PACK, Model Number DYNJ53618A; www) MSB BEDSIDE TRAY, Model Number DYNJ54670; xxx) LEE VEIN PACK, Model Number DYNJ54906C; yyy) ARTERIOGRAM PACK, Model Number DYNJ55169G; zzz) PICC LINE PACK, Model Number DYNJ55170B; aaaa) PICC LINE PACK, M
Reason for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Lot / Code Information
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART995, UDI/DI (EA) 10193489190502,UDI/DI (CS) 40193489190503; b) Model Number ARTNC145, UDI/DI (EA) 10195327306762,UDI/DI (CS) 40195327306763; c) Model Number CVI4705, UDI/DI (EA) 10193489832372,UDI/DI (CS) 40193489832373; d) Model Number CVI4805, UDI/DI (EA) 10195327068714,UDI/DI (CS) 40195327068715; e) Model Number CVI4865, UDI/DI (EA) 10195327235260,UDI/DI (CS) 40195327235261; f) Model Number CVI4950A, UDI/DI (EA) 10195327351960,UDI/DI (CS) 40195327351961; g) Model Number DT22260, UDI/DI (EA) 10653160329190,UDI/DI (CS) 40653160329191; h) Model Number DYNDA2482, UDI/DI (EA) 10193489351606,UDI/DI (CS) 40193489351607; i) Model Number DYNDA2669, UDI/DI (EA) 10193489465426,UDI/DI (CS) 40193489465427; j) Model Number DYNDA2759, UDI/DI (EA) 10193489488197,UDI/DI (CS) 40193489488198; k) Model Number DYNDA3010, UDI/DI (EA) 10195327282301,UDI/DI (CS) 40195327282302; l) Model Number DYNDC2120B, UDI/DI (EA) 10193489363357,UDI/DI (CS) 40193489363358; m) Model Number DYNDC2373A, UDI/DI (EA) 10889942492206,UDI/DI (CS) 40889942492207; n) Model Number DYNDC2582A, UDI/DI (EA) 10193489349399,UDI/DI (CS) 40193489349390; o) Model Number DYNDC3061, UDI/DI (EA) 10193489495812,UDI/DI (CS) 40193489495813; p) Model Number DYNDH1123B, UDI/DI (EA) 10193489465556,UDI/DI (CS) 40193489465557; q) Model Number DYNJ00281O, UDI/DI (EA) 10193489962963,UDI/DI (CS) 40193489962964; r) Model Number DYNJ0214541O, UDI/DI (EA) 10195327088880,UDI/DI (CS) 40195327088881; s) Model Number DYNJ0220136Q, UDI/DI (EA) 10193489823486,UDI/DI (CS) 40193489823487; t) Model Number DYNJ0235859I, UDI/DI (EA) 10193489421347,UDI/DI (CS) 40193489421348; u) Model Number DYNJ0235859J, UDI/DI (EA) 10195327069278,UDI/DI (CS) 40195327069279; v) Model Number DYNJ0235859K, UDI/DI (EA) 10195327243210,UDI/DI (CS) 40195327243211; w) Model Number DYNJ04592K, UDI/DI (EA) 10193489215205,UDI/DI (CS) 40193489215206; x) Model Number DYNJ0678523N, UDI/DI (EA) 10193489994049,UDI/DI (CS) 40193489994040; y) Model Number DYNJ0855123N, UDI/DI (EA) 10195327094881,UDI/DI (CS) 40195327094882; z) Model Number DYNJ0880659F, UDI/DI (EA) 10195327111496,UDI/DI (CS) 40195327111497; aa) Model Number DYNJ0940720D, UDI/DI (EA) 10889942550951,UDI/DI (CS) 40889942550952; bb) Model Number DYNJ09895R, UDI/DI (EA) 10195327264529,UDI/DI (CS) 40195327264520; cc) Model Number DYNJ17086A, UDI/DI (EA) 10884389064306,UDI/DI (CS) 40884389064307; dd) Model Number DYNJ20094L, UDI/DI (EA) 10195327212902,UDI/DI (CS) 40195327212903; ee) Model Number DYNJ21575I, UDI/DI (EA) 10195327009670,UDI/DI (CS) 40195327009671; ff) Model Number DYNJ30087C, UDI/DI (EA) 10889942754144,UDI/DI (CS) 40889942754145; gg) Model Number DYNJ30233C, UDI/DI (EA) 10193489382570,UDI/DI (CS) 40193489382571; hh) Model Number DYNJ30566B, UDI/DI (EA) 10889942375523,UDI/DI (CS) 40889942375524; ii) Model Number DYNJ32358G, UDI/DI (EA) 10889942526475,UDI/DI (CS) 40889942526476; jj) Model Number DYNJ33005F, UDI/DI (EA) 10193489954135,UDI/DI (CS) 40193489954136; kk) Model Number DYNJ33005G, UDI/DI (EA) 10195327319663,UDI/DI (CS) 40195327319664; ll) Model Number DYNJ34241, UDI/DI (EA) 10884389335864,UDI/DI (CS) 40884389335865; mm) Model Number DYNJ35000I, UDI/DI (EA) 10193489261646,UDI/DI (CS) 40193489261647; nn) Model Number DYNJ35163C, UDI/DI (EA) 10889942494682,UDI/DI (CS) 40889942494683; oo) Model Number DYNJ35272, UDI/DI (EA) 10884389428269,UDI/DI (CS) 40884389428260; pp) Model Number DYNJ38868K, UDI/DI (EA) 10193489657609,UDI/DI (CS) 40193489657600; qq) Model Number DYNJ38868L, UDI/DI (EA) 10195327224776,UDI/DI (CS) 40195327224777; rr) Model Number DYNJ39039M, UDI/DI (EA) 10193489898507,UDI/DI (CS) 40193489898508; ss) Model Number DYNJ40204B, UDI/DI (EA) 10195327178451,UDI/DI (CS) 40195327178452; tt) Model Number DYNJ40206B, UDI/DI (EA) 10195327176440,UDI/DI (CS) 40195327176441; uu) Model Number DYNJ40682B, UDI/DI (EA) 10889942267217,UDI/DI (CS) 40889942267218; vv) Model Number DYNJ40990C, UDI/DI (EA) 10889942024377,UDI/DI (CS) 40889942024378; ww) Model Number DYNJ41554C, UDI/DI (EA) 10889942811328,UDI/DI (CS) 40889942811329; xx) Model Number DYNJ41648, UDI/DI (EA) 10884389909171,UDI/DI (CS) 40884389909172; yy) Model Number DYNJ42902C, UDI/DI (EA) 10195327084684,UDI/DI (CS) 40195327084685; zz) Model Number DYNJ42902D, UDI/DI (EA) 10195327171100,UDI/DI (CS) 40195327171101; aaa) Model Number DYNJ43168, UDI/DI (EA) 10888277034891,UDI/DI (CS) 40888277034892; bbb) Model Number DYNJ43168A, UDI/DI (EA) 10195327084707,UDI/DI (CS) 40195327084708; ccc) Model Number DYNJ43168B, UDI/DI (EA) 10195327224523,UDI/DI (CS) 40195327224524; ddd) Model Number DYNJ43267G, UDI/DI (EA) 10195327288808,UDI/DI (CS) 40195327288809; eee) Model Number DYNJ43975A, UDI/DI (EA) 10888277882447,UDI/DI (CS) 40888277882448; fff) Model Number DYNJ43981G, UDI/DI (EA) 10193489223538,UDI/DI (CS) 40193489223539; ggg) Model Number DYNJ44737C, UDI/DI (EA) 10195327277871,UDI/DI (CS) 40195327277872; hhh) Model Number DYNJ44904C, UDI/DI (EA) 10193489858679,UDI/DI (CS) 40193489858670; iii) Model Number DYNJ47037C, UDI/DI (EA) 10193489616002,UDI/DI (CS) 40193489616003; jjj) Model Number DYNJ47717B, UDI/DI (EA) 10195327355302,UDI/DI (CS) 40195327355303; kkk) Model Number DYNJ48096B, UDI/DI (EA) 10888277939318,UDI/DI (CS) 40888277939319; lll) Model Number DYNJ48120B, UDI/DI (EA) 10888277894877,UDI/DI (CS) 40888277894878; mmm) Model Number DYNJ48428C, UDI/DI (EA) 10193489702477,UDI/DI (CS) 40193489702478; nnn) Model Number DYNJ49180A, UDI/DI (EA) 10888277863569,UDI/DI (CS) 40888277863560; ooo) Model Number DYNJ49235D, UDI/DI (EA) 10193489894332,UDI/DI (CS) 40193489894333; ppp) Model Number DYNJ52255, UDI/DI (EA) 10889942253708,UDI/DI (CS) 40889942253709; qqq) Model Number DYNJ52688B, UDI/DI (EA) 10193489452471,UDI/DI (CS) 40193489452472; rrr) Model Number DYNJ52688C, UDI/DI (EA) 10195327301026,UDI/DI (CS) 40195327301027; sss) Model Number DYNJ52894A, UDI/DI (EA) 10889942437542,UDI/DI (CS) 40889942437543; ttt) Model Number DYNJ53095A, UDI/DI (EA) 10195327148720,UDI/DI (CS) 40195327148721; uuu) Model Number DYNJ53435D, UDI/DI (EA) 10195327196448,UDI/DI (CS) 40195327196449; vvv) Model Number DYNJ53618A, UDI/DI (EA) 10889942492497,UDI/DI (CS) 40889942492498; www) Model Number DYNJ54670, UDI/DI (EA) 10889942499571,UDI/DI (CS) 40889942499572; xxx) Model Number DYNJ54906C, UDI/DI (EA) 10195327188764,UDI/DI (CS) 40195327188765; yyy) Model Number DYNJ55169G, UDI/DI (EA) 10193489967562,UDI/DI (CS) 40193489967563; zzz) Model Number DYNJ55170B, UDI/DI (EA) 10193489967579,UDI/DI (CS) 40193489967570; aaaa) Model Number DYNJ55170C, UDI/DI (EA) 10195327135355,UDI/DI (CS) 40195327135356; bbbb) Model Number DYNJ55546D, UDI/DI (EA) 10195327056520,UDI/DI (CS) 40195327056521; cccc) Model Number DYNJ56029A, UDI/DI (EA) 10195327347826,UDI/DI (CS) 40195327347827; dddd) Model Number DYNJ56857C, UDI/DI (EA) 10193489967586,UDI/DI (CS) 40193489967587; eeee) Model Number DYNJ56857D, UDI/DI (EA) 10195327280963,UDI/DI (CS) 40195327280964; ffff) Model Number DYNJ57112, UDI/DI (EA) 10889942721597,UDI/DI (CS) 40889942721598; gggg) Model Number DYNJ57793A, UDI/DI (EA) 10193489846027,UDI/DI (CS) 40193489846028; hhhh) Model Number DYNJ59246A, UDI/DI (EA) 10195327039110,UDI/DI (CS) 40195327039111; iiii) Model Number DYNJ59751B, UDI/DI (EA) 10193489695915,UDI/DI (CS) 40193489695916; jjjj) Model Number DYNJ60038A, UDI/DI (EA) 10195327038335,UDI/DI (CS) 40195327038336; kkkk) Model Number DYNJ60329A, UDI/DI (EA) 10193489972221,UDI/DI (CS) 40193489972222; llll) Model Number DYNJ60990B, UDI/DI (EA) 10193489921700,UDI/DI (CS) 40193489921701; mmmm) Model Number DYNJ62038B, UDI/DI (EA) 10193489898491,UDI/DI (CS) 40193489898492; nnnn) Model Number DYNJ62711A, UDI/DI (EA) 10193489233018,UDI/DI (CS) 40193489233019; oooo) Model Number DYNJ62889A, UDI/DI (EA) 10193489971125,UDI/DI (CS) 40193489971126; pppp) Model Number DYNJ62889B, UDI/DI (EA) 10195327030957,UDI/DI (CS) 40195327030958; qqqq) Model Number DYNJ63162, UDI/DI (EA) 10193489720891,UDI/DI (CS) 40193489720892; rrrr) Model Number DYNJ63213, UDI/DI (EA) 10193489728217,UDI/DI (CS) 40193489728218; ssss) Model Number DYNJ63268C, UDI/DI (EA) 10195327077167,UDI/DI (CS) 40195327077168; tttt) Model Number DYNJ63268D, UDI/DI (EA) 10195327132217,UDI/DI (CS) 40195327132218; uuuu) Model Number DYNJ63268F, UDI/DI (EA) 10195327297114,UDI/DI (CS) 40195327297115; vvvv) Model Number DYNJ63590, UDI/DI (EA) 10193489769180,UDI/DI (CS) 40193489769181; wwww) Model Number DYNJ64141A, UDI/DI (EA) 10195327279578,UDI/DI (CS) 40195327279579; xxxx) Model Number DYNJ64190B, UDI/DI (EA) 10195327281281,UDI/DI (CS) 40195327281282; yyyy) Model Number DYNJ64249A, UDI/DI (EA) 10193489381368,UDI/DI (CS) 40193489381369; zzzz) Model Number DYNJ64337, UDI/DI (EA) 10193489800289,UDI/DI (CS) 40193489800280;
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.