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
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.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 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.
- Location
- Northfield, IL
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