Recall archive / FDA device enforcement
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN H... — FDA record Z-2302-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C; d. OPEN HEART PACK A B, Model Number: DYNJ53984G; e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G; f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N; g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W; h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P; i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A; j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B; k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F; l. OPEN VASCULAR UE, Model Number: DYNJ907858A; m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451; n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C; o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295; p. PACER SET UP PACK, Model Number: DYNJ63069A; q. PACK AV FISTULA, Model Number: DYNJ60115B; r. PACK MINOR VASCULAR, Model Number: NG340C; s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D; t. PEDI EP PACK, Model Number: DYNJ54750G; u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G; v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I; w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A; x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I; y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C; z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566; aa. PERMA CATH PACK, Model Number: DYNJ62007B; bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010; cc. PK OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A; dd. PK, OPEN HEART, Model Number: DYNJ61645A; ee. PK, VASCULAR, Model Number: DYNJ54305; ff. PORT PACK, Model Number: DYNJ68990A; gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A; hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492; ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618; jj. PRX AV FISTULA PACK, Model Number: DYNJ66184; kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C; ll. PUMP PACK, Model Number: DYNJ64601B; mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B; nn. PV CAROTID PACK, Model Number: DYNJ63341D; oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L; pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K; qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A; rr. RFD-CAROTID, Model Number: DYNJ54287B; ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A; tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B; uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B; vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U; ww. RIGHT HEART TRAY, Model Number: DYNJ40379D; xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C; yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L; zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908...
- Reason
- Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 43,149 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2302-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: CDS840451L, UPC Number: 019532715163. b. Model Number: DYNJ908179, UPC Number: 019348999908; Model Number: DYNJ908179A, UPC Number: 019532722257. c. Model Number: DYNJ43741B, UPC Number: 088994282107; Model Number: DYNJ66216, UPC Number: 019348932622; Model Number: DYNJ66216A, UPC Number: 019348991365; Model Number: DYNJ66216B, UPC Number: 019532703430; Model Number: DYNJ66216C, UPC Number: 019532734492. d. Model Number: DYNJ53984G, UPC Number: 019532728288. e. Model Number: DYNJ0283397T, UPC Number: 019348956435; Model Number: DYNJ0283397U, UPC Number: 019532708366; Model Number: DYNJ53984F, UPC Number: 019348946948; Model Number: DYNJ53984G, UPC Number: 019532728288. f. Model Number: DYNJ0371669N, UPC Number: 019348923039. g. Model Number: DYNJ22232W, UPC Number: 019532732560. h. Model Number: DYNJ901075O, UPC Number: 019532705268; Model Number: DYNJ901075P, UPC Number: 019532725355. i. Model Number: DYNJ901821A, UPC Number: 019532731932. j. Model Number: DYNJ63153B, UPC Number: 019348984168. k. Model Number: DYNJ63099F, UPC Number: 019532715003. l. Model Number: DYNJ907858A, UPC Number: 019532713135. m. Model Number: DYNJ62451, UPC Number: 019348965833. n. Model Number: DYNJ906019C, UPC Number: 019348941128. o. Model Number: DYNJ81295, UPC Number: 019532710670. p. Model Number: DYNJ63069A, UPC Number: 019348942361. q. Model Number: DYNJ60115B, UPC Number: 019532711880. r. Model Number: NG340C, UPC Number: 019532730520. s. Model Number: DYNJ905692D, UPC Number: 019532720229. t. Model Number: DYNJ54750G, UPC Number: 019532702135. u. Model Number: DYNJ35578G, UPC Number: 019348980860. v. Model Number: CDS840487I, UPC Number: 019348944534. w. Model Number: PAIN1423A, UPC Number: 019348920182. x. Model Number: DYNJ44562F, UPC Number: 019348973734; Model Number: DYNJ901068D, UPC Number: 019348921186; Model Number: DYNJ901068F, UPC Number: 019348994461; Model Number: DYNJ901068I, UPC Number: 019532723251. y. Model Number: SYNJ910022A, UPC Number: 019348937421; Model Number: SYNJ910022B, UPC Number: 019532700726; Model Number: SYNJ910022C, UPC Number: 019532735820. z. Model Number: DYNJ82566, UPC Number: 019532719802. aa. Model Number: DYNJ62007B, UPC Number: 019532716196. bb. Model Number: PICCNC0010, UPC Number: 019532723117. cc. Model Number: DYNJ45074C, UPC Number: 019348922267; Model Number: DYNJ61645A, UPC Number: 019348978134. dd. Model Number: DYNJ61645A, UPC Number: 019348978134. ee. Model Number: DYNJ54305, UPC Number: 088994247639. ff. Model Number: DYNJ68990A, UPC Number: 019348998136. gg. Model Number: DYNJ65775A, UPC Number: 019532714022. hh. Model Number: DYNJ68492, UPC Number: 019348982724. ii. Model Number: DYNJ43922, UPC Number: 088827707466; Model Number: DYNJ68968A, UPC Number: 019532720684; Model Number: DYNJ81618, UPC Number: 019532712460. jj. Model Number: DYNJ66184, UPC Number: 019348932118. kk. Model Number: DYNJ907554A, UPC Number: 019532702463; Model Number: DYNJ907554C, UPC Number: 019532718383. ll. Model Number: DYNJ64601B, UPC Number: 019532728473. mm. Model Number: DYNJ62197A, UPC Number: 019348999409; Model Number: DYNJ62197B, UPC Number: 019532716724. nn. Model Number: DYNJ63341D, UPC Number: 019532727362. oo. Model Number: DYNJ46549K, UPC Number: 019532700829; Model Number: DYNJ46549L, UPC Number: 019532729066. pp. Model Number: DYNJ47660K, UPC Number: 019348987573. qq. Model Number: DYNJ61894A, UPC Number: 019348973096. rr. Model Number: DYNJ54287B, UPC Number: 019532716711. ss. Model Number: DYNJ54265A, UPC Number: 019532715233. tt. Model Number: DYNJ54285B, UPC Number: 019532714203. uu. Model Number: DYNJ54286B, UPC Number: 019532714578. vv. Model Number: DYNJ0565558U, UPC Number: 019348982703. ww. Model Number: DYNJ40379D, UPC Number: 019348925761. xx. Model Number: DYNJ55757C, UPC Number: 019532711653. yy. Model Number: DYNJ33544J, UPC Number: 019348956435; Model Number: DYNJ33544K, UPC Number: 019348956435; Model Number: DYNJ33544L, UPC Number: 019532727931. zz. Model Number: DYNJ908074B, UPC Number: 019532717268. aaa. Model Number: DYNJ63817, UPC Number: 019348976395. bbb. Model Number: DYNJ906102D, UPC Number: 019348982234; Model Number: DYNJ906102F, UPC Number: 019532702826. ccc. Model Number: DYNJ83521, UPC Number: 019532727464. ddd. Model Number: DYNJ65418, UPC Number: 019348927371. eee. Model Number: DYNJ82314, UPC Number: 019532718421. fff. Model Number: DYNJ49833I, UPC Number: 019348988536. ggg. Model Number: DYNJ20031C, UPC Number: 088438965007. hhh. Model Number: DYNJ80918, UPC Number: 019532708492. iii. Model Number: DYNJ908563, UPC Number: 019532708642. jjj. Model Number: DYNJ80506, UPC Number: 019532704917. kkk. Model Number: DYNJ69009, UPC Number: 019348987684; Model Number: DYNJ69009A, UPC Number: 019532707556. lll. Model Number: DYNJ54014B, UPC Number: 088994276032. mmm. Model Number: DYNJ43861F, UPC Number: 019348998164. nnn. Model Number: DYNJ48153F, UPC Number: 019348998969. ooo. Model Number: DYNJ43777J, UPC Number: 019348999018. ppp. Model Number: DYNJ57539B, UPC Number: 019348930066; Model Number: DYNJ907561, UPC Number: 019348982123; Model Number: DYNJ907561A, UPC Number: 019532702884; Model Number: DYNJ908646, UPC Number: 019532712395; Model Number: DYNJ908646A, UPC Number: 019532731496. qqq. Model Number: DYNJ904401C, UPC Number: 019348934891; Model Number: DYNJ905859, UPC Number: 019348954552. rrr. Model Number: DYNJ52766A, UPC Number: 019348929236; Model Number: DYNJ62915B, UPC Number: 019348936535; Model Number: DYNJ63340A, UPC Number: 019532727358; Model Number: DYNJ66769, UPC Number: 019348938052; Model Number: DYNJ68933, UPC Number: 019348986037; Model Number: DYNJ81095, UPC Number: 019532708412; Model Number: DYNJ82863A, UPC Number: 019532724504. sss. Model Number: DYNJ66152A, UPC Number: 019348982021; Model Number: DYNJ66152B, UPC Number: 019532709042. ttt. Model Number: DYNJ906391D, UPC Number: 019532702147. uuu. Model Number: DYNJ903919J, UPC Number: 019532704590; Model Number: DYNJ903919K, UPC Number: 019532721878; Model Number: DYNJ903919L, UPC Number: 019532726705. vvv. Model Number: DYNJ64449, UPC Number: 019348920157. www. Model Number: TVS4000L, UPC Number: 019532722354. xxx. Model Number: DYNJ55427B, UPC Number: 019348978611; Model Number: DYNJ55427C, UPC Number: 019532712656; Model Number: DYNJ55427D, UPC Number: 019532727261. yyy. Model Number: DYNJ907201, UPC Number: 019348935833; Model Number: DYNJ907201B, UPC Number: 019348994665. zzz. Model Number: DYNJ69622, UPC Number: 019348995958. aaaa. Model Number: DYNJ69302, UPC Number: 019348992627. bbbb. Model Number: DYNJ81705, UPC Number: 019532713557. cccc. Model Number: DYNJ906882A, UPC Number: 019348939123. dddd. Model Number: DYNJ58915, UPC Number: 088994290385; Model Number: DYNJ65842, UPC Number: 019348929631. eeee. Model Number: CDS985355C, UPC Number: 019348931018; Model Number: CDS985355D, UPC Number: 019348944277; Model Number: CDS985355F, UPC Number: 019532724262; Model Number: DYNJ900293J, UPC Number: 019348991514; Model Number: DYNJ902554I, UPC Number: 019348921874; Model Number: DYNJ902704P, UPC Number: 019348986337; Model Number: DYNJ904397D, UPC Number: 019348970120; Model Number: DYNJ904397F, UPC Number: 019348997971; Model Number: DYNJ906021B, UPC Number: 019348941129; Model Number: DYNJ906883A, UPC Number: 019348939820; Model Number: DYNJ909007, UPC Number: 019532724004; Model Number: DYNJ909091, UPC Number: 019532726860. ffff. Model Number: DYNJ59796C, UPC Number: 019348990421. gggg. Model Number: DYNJ81022, UPC Number: 019532708278. hhhh. Model Number: DYNDA2526, UPC Number: 019348919179. iiii. Model Number: DYNJ52606C, UPC Number: 019348973825; Model Number: DYNJ52606D, UPC Number: 019348981280; Model Number: DYNJ52606F, UPC Number: 019348934329. jjjj. Model Number: DYNJ905285C, UPC Number: 019348994725. kkkk. Model Number: DYNJ44420C, UPC Number: 019348959033; Model Number: DYNJ82698, UPC Number: 019532720300. llll. Model Number: DYNJ82109, UPC Number: 019532717124. mmmm. Model Number: DYNJ902259B, UPC Number: 019348991971. nnnn. Model Number: DYNJ904984, UPC Number: 088994278935, Model Number: DYNJ904984B, UPC Number: 019348981293. oooo. Model Number: CDS983040J, UPC Number: 019348924185; Model Number: CDS983040K, UPC Number: 019348984199; Model Number: CDS983136F, UPC Number: 019348921152; Model Number: CDS983136G, UPC Number: 019532714892. pppp. Model Number: CDS982751K, UPC Number: 019348982501. qqqq. Model Number: CDS983390G, UPC Number: 019348982050; Model Number: CDS983390I, UPC Number: 019532710364; Model Number: CDS983390J, UPC Number: 019532720540. rrrr. Model Number: DYNJ902261F, UPC Number: 019348927536; Model Number: DYNJ902261G, UPC Number: 019348991972; Model Number: DYNJ905859, UPC Number: 019348954552. ssss. Model Number: DYNJ37445I, UPC Number: 019348941739. tttt. Model Number: DYNJ81023, UPC Number: 019532708279. uuuu. Model Number: DYNJ53433F, UPC Number: 019348932867. vvvv. Model Number: DYNJ81200, UPC Number: 019532709169; Model Number: DYNJ81200A, UPC Number: 019532722471. wwww. Model Number: DYNJ81642A, UPC Number: 019532726638. xxxx. Model Number: DYNJVB91050A, UPC Number: 019532717172. yyyy. Model Number: DYNJ46100G, UPC Number: 019348926846; Model Number: DYNJ46100I, UPC Number: 019348985640. zzzz. Model Number: DYNJ0103507AF, UPC Number: 019348956435; Model Number: DYNJ0103507AI, UPC Number: 019348956435; Model Number: DYNJ0103507AJ, UPC Number: 019532730242. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 9, 2023
- Recall initiation date
- May 15, 2023
- Center classification date
- Aug 3, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.