PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported August 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Numb

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

Recall #
Z-2305-2023
Affected scope
146,157 kits
Initiated
May 15, 2023
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Medline Industries, LP - Northfield recalled Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labele… - a moderate-severity action.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labele… was recalled by Medline Industries, LP - Northfield in August 9, 2023. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.. Check the official notice for the remedy. Verify recall #Z-2305-2023 with the FDA Devices before acting.

The recall

Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall-Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..

Moderate
severity level
Class II
classification
August 9, 2023
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2305-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Number: DYNJ49235D; i. ARTERIOGRAM PACK, Model Number: DYNJ53095A, DYNJ55169G; j. AV FISTULA, Model Number: DYNJ64143A, DYNJ905219A, DYNJ906341C, DYNJ906945; k. AV FISTULA PACK, Model Number: DYNJ52093I, DYNJ62733, DYNJ66916, DYNJ67178; l. AV FISTULA PACK-LF, Model Number: DYNJ48428C, DYNJ64499A, DYNJ69167; m. AV SHUNT PACK-LF, Model Number: DYNJ0781844W; n. BARIATRIC KIT, Model Number: DYNJ901145F; o. BASIC VEIN PACK, Model Number: DYNJ69426; p. BCH VEIN ABLATION, Model Number: DYNJ69796; q. CATH LAB-VEIN PROCEDURES, Model Number: DYNJ60329A; r. CENTRAL LINE BUNDLE PACK-LF, Model Number: DYNJ22338K; s. CENTRAL LINE INSERTION KIT, Model Number: DYNJ52894A; t. CENTRAL LINE INSERTION PACK, Model Number: CVI4805; u. CENTRAL LINE KIT, Model Number: DYNDC2582A; v. CENTRAL LINE KIT UTMB, Model Number: DYNDC3061; w. CENTRAL LINE PACK, Model Number: DYNJ30087C, DYNJ48096B; x. CENTRAL LINE PACK-LF, Model Number: DYNJ0220136Q; y. CENTRAL LINE PLACEMENT PACK-LF, Model Number: DYNJ32358G; z. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; aa. CENTRAL LINE TRAY, Model Number: CVI4705; bb. CENTRAL VENOUS ACCESS PACK-LF, Model Number: DYNJ0214541O; cc. CVC/PICC INSERTION PACK EH-LF, Model Number: DYNJ40204A, DYNJ40204B; dd. CVL PACK, Model Number: DYNJ00281O; ee. CVR ENDOVENOUS PACK, Model Number: DYNJ80643; ff. DBD-AV FISTULA, Model Number: DYNJ904398D; gg. DBD-CENTRAL LINE TRAY, Model Number: DYNJ42902C; hh. DBD-LEE VEIN PACK, Model Number: DYNJ54906C; ii. DBD-PICC LINE PACK-LF, Model Number: DYNJ0373077O; jj. DBD-VARICOSE VEIN PACK, Model Number: DYNJ82884, DYNJ82885; kk. DBD-VASCULAR PACK-LF, Model Number: DYNJ56968; ll. DBD-VASCULAR VEIN PACK, Model Number: DYNJ69769; mm. DBD-VEIN PACK, Model Number: DYNJ82033; nn. DBD-VENCLOSE PROCEDURE PACK, Model Number: DYNJ80123; oo. DBD-VENOUS ACCESS PORT INSERTION, Model Number: DYNJ902602I; pp. DBD-VENOUS PACK, Model Number: DYNJ44243C, DYNJ80692; qq. DECLOT ACCESS, Model Number: DYNJ907279A, DYNJ907279B; rr. DEXMED ACCESS PACK, Model Number: DYNJ83148; ss. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435D; tt. ENS PICC LINE-HEJ-LF, Model Number: DYNJ67606; uu. ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; vv. ER CENTRAL LINE KIT, Model Number: P155508D; ww. FISTULA SAVANNAH PACK, Model Number: DYNJ69943; xx. FISTULAGRAM PACK-LF, Model Number: DYNJ63213; yy. FNA TRAY, Model Number: DYNDH1123B; zz. GENERAL AV FISTULA, Model Number: DYNJ906011B; aaa. GROTH LASER VEIN CDS, Model Number: CDS984193Q; bbb. I.R. PICC PACK, Model Number: DYNDA2759; ccc. IR CENTRAL VENOUS ACCESS, Model Number: DYNJ43267G; ddd. IR PICC TRAY, Model Number: DYNDH1223; eee. JVL-PACK PICC, Model Number: DYNJ66062; fff. KIT MAJOR VASCULAR, Model Number: DYNJ907262A; ggg. KIT VEIN ABLATION, Model Number: DYNJ907381; hhh. LASER VEIN EC PACK, Model Number: DYNJ82951; iii. MAX BARRIER ART LINE KIT, Model Number: ART950; jjj. MHC AV FISTULA, Model Number: DYNJ903705G; kkk. MID HUDSON PICC LINE PACK, Model Number: DYNJ53618A; lll. MIDLINE INSERTION KIT, Model Number: DYNJ45178; mmm. MSB BEDSIDE TRAY, Model Number: DYNJ54670; nnn. MV-IR-PICC PACK-LF, Model Number: DYNJ41554C; ooo. NENTRAL LINE TRAY, Model Number: DYNJ42902D; ppp. NEONATAL PICC LINE TRAY, Model Number: DYNDC2120B; qqq. OPEN VASCULA

Reason for recall

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-2305-2023
Date reported August 9, 2023
Date initiated May 15, 2023
Recalling firm Medline Industries, LP - Northfield
Firm location Northfield, IL
Affected scope 146,157 kits
Distribution Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2305-2023) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Number: DYNJ49235D; i. ARTERIOGRAM PACK, Model Number: DYNJ53095A, DYNJ55169G; j. AV FISTULA, Model Number: DYNJ64143A, DYNJ905219A, DYNJ906341C, DYNJ906945; k. AV FISTULA PACK, Model Number: DYNJ52093I, DYNJ62733, DYNJ66916, DYNJ67178; l. AV FISTULA PACK-LF, Model Number: DYNJ48428C, DYNJ64499A, DYNJ69167; m. AV SHUNT PACK-LF, Model Number: DYNJ0781844W; n. BARIATRIC KIT, Model Number: DYNJ901145F; o. BASIC VEIN PACK, Model Number: DYNJ69426; p. BCH VEIN ABLATION, Model Number: DYNJ69796; q. CATH LAB-VEIN PROCEDURES, Model Number: DYNJ60329A; r. CENTRAL LINE BUNDLE PACK-LF, Model Number: DYNJ22338K; s. CENTRAL LINE INSERTION KIT, Model Number: DYNJ52894A; t. CENTRAL LINE INSERTION PACK, Model Number: CVI4805; u. CENTRAL LINE KIT, Model Number: DYNDC2582A; v. CENTRAL LINE KIT UTMB, Model Number: DYNDC3061; w. CENTRAL LINE PACK, Model Number: DYNJ30087C, DYNJ48096B; x. CENTRAL LINE PACK-LF, Model Number: DYNJ0220136Q; y. CENTRAL LINE PLACEMENT PACK-LF, Model Number: DYNJ32358G; z. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; aa. CENTRAL LINE TRAY, Model Number: CVI4705; bb. CENTRAL VENOUS ACCESS PACK-LF, Model Number: DYNJ0214541O; cc. CVC/PICC INSERTION PACK EH-LF, Model Number: DYNJ40204A, DYNJ40204B; dd. CVL PACK, Model Number: DYNJ00281O; ee. CVR ENDOVENOUS PACK, Model Number: DYNJ80643; ff. DBD-AV FISTULA, Model Number: DYNJ904398D; gg. DBD-CENTRAL LINE TRAY, Model Number: DYNJ42902C; hh. DBD-LEE VEIN PACK, Model Number: DYNJ54906C; ii. DBD-PICC LINE PACK-LF, Model Number: DYNJ0373077O; jj. DBD-VARICOSE VEIN PACK, Model Number: DYNJ82884, DYNJ82885; kk. DBD-VASCULAR PACK-LF, Model Number: DYNJ56968; ll. DBD-VASCULAR VEIN PACK, Model Number: DYNJ69769; mm. DBD-VEIN PACK, Model Number: DYNJ82033; nn. DBD-VENCLOSE PROCEDURE PACK, Model Number: DYNJ80123; oo. DBD-VENOUS ACCESS PORT INSERTION, Model Number: DYNJ902602I; pp. DBD-VENOUS PACK, Model Number: DYNJ44243C, DYNJ80692; qq. DECLOT ACCESS, Model Number: DYNJ907279A, DYNJ907279B; rr. DEXMED ACCESS PACK, Model Number: DYNJ83148; ss. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435D; tt. ENS PICC LINE-HEJ-LF, Model Number: DYNJ67606; uu. ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; vv. ER CENTRAL LINE KIT, Model Number: P155508D; ww. FISTULA SAVANNAH PACK, Model Number: DYNJ69943; xx. FISTULAGRAM PACK-LF, Model Number: DYNJ63213; yy. FNA TRAY, Model Number: DYNDH1123B; zz. GENERAL AV FISTULA, Model Number: DYNJ906011B; aaa. GROTH LASER VEIN CDS, Model Number: CDS984193Q; bbb. I.R. PICC PACK, Model Number: DYNDA2759; ccc. IR CENTRAL VENOUS ACCESS, Model Number: DYNJ43267G; ddd. IR PICC TRAY, Model Number: DYNDH1223; eee. JVL-PACK PICC, Model Number: DYNJ66062; fff. KIT MAJOR VASCULAR, Model Number: DYNJ907262A; ggg. KIT VEIN ABLATION, Model Number: DYNJ907381; hhh. LASER VEIN EC PACK, Model Number: DYNJ82951; iii. MAX BARRIER ART LINE KIT, Model Number: ART950; jjj. MHC AV FISTULA, Model Number: DYNJ903705G; kkk. MID HUDSON PICC LINE PACK, Model Number: DYNJ53618A; lll. MIDLINE INSERTION KIT, Model Number: DYNJ45178; mmm. MSB BEDSIDE TRAY, Model Number: DYNJ54670; nnn. MV-IR-PICC PACK-LF, Model Number: DYNJ41554C; ooo. NENTRAL LINE TRAY, Model Number: DYNJ42902D; ppp. NEONATAL PICC LINE TRAY, Model Number: DYNDC2120B; qqq. OPEN VASCULA. Recalled by Medline Industries, LP - Northfield. Units affected: 146,157 kits.
Why was this product recalled? ▼
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2305-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates..
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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