Severity
Moderate
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. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595; e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V; f. CVC 16CM BUNDLE, Model Number: ECVC2225; g. CVC 3L 7F 20CM VANT
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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-2298-2023 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-2298-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2298-2023) was formally reported on August 9, 2023, with the manufacturer initiating the action on May 15, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 76,870 kits.
The documented reason for this recall is: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
76,870 kits
Related Recalls
6
3 from same agency
Product description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595; e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V; f. CVC 16CM BUNDLE, Model Number: ECVC2225; g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A; h. CVC BUNDLE, Model Number: ECVC3235; i. CVC BUNDLE 16CM, Model Number: ECVC2335; j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B; k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B; l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460; m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A; n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001; o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A; p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200; q. CVC BUNDLE KIT OR, Model Number: ECVC2205; r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A; s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120; u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150; v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B; w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105; x. CVC HEART PACK, Model Number: ECVC7360; y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A; z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860; aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895; bb. CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315; cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310; dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555; ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286; ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A; gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A; hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525; jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850; kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A; ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300; mm. CVC KIT WITH CATHETER, Model Number: ECVC885; nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105; oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B; pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235; qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B; rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B; ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400; tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465; uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070; vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940; ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J; xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L; yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297; zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D; aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A; ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531; ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336; eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G; fff. DIALYSIS TRAY, Model Number: DYNJ43060B; ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A; hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985; iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940; jjj. ECMO PACK 2, Model Number: DYNJ82079; kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691; lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B; mmm. EPS PACK, Model Number: DYNJ46545C; nnn. EV LAB PACK, Mo
Reason for recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2298-2023 |
| Date reported | August 9, 2023 |
| Date initiated | May 15, 2023 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | 76,870 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-2298-2023) 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. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595; e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V; f. CVC 16CM BUNDLE, Model Number: ECVC2225; g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A; h. CVC BUNDLE, Model Number: ECVC3235; i. CVC BUNDLE 16CM, Model Number: ECVC2335; j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B; k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B; l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460; m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A; n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001; o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A; p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200; q. CVC BUNDLE KIT OR, Model Number: ECVC2205; r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A; s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120; u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150; v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B; w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105; x. CVC HEART PACK, Model Number: ECVC7360; y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A; z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860; aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895; bb. CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315; cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310; dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555; ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286; ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A; gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A; hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525; jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850; kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A; ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300; mm. CVC KIT WITH CATHETER, Model Number: ECVC885; nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105; oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B; pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235; qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B; rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B; ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400; tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465; uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070; vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940; ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J; xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L; yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297; zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D; aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A; ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531; ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336; eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G; fff. DIALYSIS TRAY, Model Number: DYNJ43060B; ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A; hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985; iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940; jjj. ECMO PACK 2, Model Number: DYNJ82079; kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691; lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B; mmm. EPS PACK, Model Number: DYNJ46545C; nnn. EV LAB PACK, Mo. Recalled by Medline Industries, LP - Northfield. Units affected: 76,870 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-2298-2023.
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2298-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 9, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.