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. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095; e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A; f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A; g. 16CM TRIPLE

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

Recall #
Z-2297-2023
Affected scope
97,677 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-2297-2023 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-2297-2023 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. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095; e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A; f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A; g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125; i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B; j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325; k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335; m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160; n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560; o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075; q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055; r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US; t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470; v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170; w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545; x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B; y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350; z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475; bb. 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770; cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370; dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910; ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905; ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795; gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705; hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355; ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640; jj. ABLATION EP PACK, Model Number: DYNJ43851B; kk. ABLATION PACK, Model Number: DYNJ40629C; ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N; mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B; nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S; oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X; pp. ANGIO CATH PACK, Model Number: DYNJ52000B; qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J; rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F; ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D; tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951; uu. ANGIO PACK-LF, Model Number: DYNJ0407399P; vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944; ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A; xx. ANGIO/PICC PACK, Model Number: DYNJ36049A; yy. ANGIOGRAM, Model Number: DYNJ0149444N; zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A; aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G; bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A; ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V; ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J; eee

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-2297-2023
Date reported August 9, 2023
Date initiated May 15, 2023
Recalling firm Medline Industries, LP - Northfield
Firm location Northfield, IL
Affected scope 97,677 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-2297-2023) 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. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095; e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A; f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A; g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125; i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B; j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325; k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335; m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160; n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560; o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075; q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055; r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US; t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470; v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170; w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545; x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B; y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350; z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475; bb. 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770; cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370; dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910; ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905; ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795; gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705; hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355; ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640; jj. ABLATION EP PACK, Model Number: DYNJ43851B; kk. ABLATION PACK, Model Number: DYNJ40629C; ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N; mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B; nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S; oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X; pp. ANGIO CATH PACK, Model Number: DYNJ52000B; qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J; rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F; ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D; tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951; uu. ANGIO PACK-LF, Model Number: DYNJ0407399P; vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944; ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A; xx. ANGIO/PICC PACK, Model Number: DYNJ36049A; yy. ANGIOGRAM, Model Number: DYNJ0149444N; zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A; aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G; bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A; ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V; ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J; eee. Recalled by Medline Industries, LP - Northfield. Units affected: 97,677 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-2297-2023.
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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Methodology · Corrections · Archive as of August 2026