Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz… — Class II medical device recall Z-2297-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-08-09, distributed nationwide. Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
| Recall number | Z-2297-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-05-15 |
| Classified | 2023-08-03 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CR, IN, LB, PA, QA, SA, SG |
| Quantity | 97,677 kits |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 00019348938623, 00019348946871, 00019348995282, 00019348996630, 00019532707035, 00019532709688, 00019532718420, 00019532722878, 00019532726791, 00088994271392, 10195327188818, 10195327310608, 10653160311829, 10653160331889, 10653160331964, 10653160332473, 10653160332671, 10653160332770, 10653160332855, 10653160333395, 10653160333425, 10653160333494, 10653160334071, 10653160334200, 10653160334217 and 57 more |
| Model numbers | 00-400305R, DYNJ0037936C, DYNJ0037936D, DYNJ0149444N, DYNJ0290716M, DYNJ0313233V, DYNJ0313233W, DYNJ0313233X, DYNJ0378596I, DYNJ0378596J, DYNJ0407399P, DYNJ0842644F, DYNJ0854485V, DYNJ0855138P, DYNJ0855138Q, DYNJ23438M, DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N, DYNJ33709F, DYNJ33739G, DYNJ36049A, DYNJ38866D, DYNJ38866F and 156 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2297-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.