Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PA... — FDA record Z-2300-2023

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. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d. ABLATION PACK, Model Number: DYNJ61957A; e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F; f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M; g. AFIB PACK, Model Number: DYNJ69682; h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F; i. ANGIO-VASCULAR, Model Number: DYNJ24272C; j. ARM VASCULAR-LF, Model Number: DYNJ905290D; k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038; l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A; m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051; n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D; o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C; p. AV FIST PACK, Model Number: DYNJ83462; q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096; r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570; s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477; t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C; u. AV FISTULA VASCULAR, Model Number: DYNJ67340; v. AV GRAFT, Model Number: DYNJ903457D; w. AV GRAFT-LF, Model Number: DYNJ40077F; x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I; y. BEDSIDE PICC CDS, Model Number: CDS984642; z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339; aa. C V MAJOR PACK, Model Number: DYNJ64861A; bb. C V MINOR PACK, Model Number: DYNJ64862B; cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G; dd. CABG HEART CDS, Model Number: CDS985384C; ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F; ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A; gg. CARDIAC A B PACK-LF, Model Number: DYNJV0177AG; hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG; ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B; jj. CARDIAC CABG PACK, Model Number: DYNJ903072R; kk. CARDIAC CATH PACK, Model Number: DYNJ41195D; ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M; mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A; nn. CARDIOLOGY EP, Model Number: DYNJ59968; oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F; pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D; qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A; rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A; ss. CAROTID PACK-LF, Model Number: DYNJ57646C; tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369; uu. CAROTID VASCULAR PACK, Model Num...
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
46,124 kits
Agency-reported status
Ongoing
Source record identifier
Z-2300-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityAll lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ44847I, UPC Number: 019532712755. b. Model Number: DYNJ82578, UPC Number: 019532719814. c. Model Number: DYNJ905291B, UPC Number: 019348995037; Model Number: DYNJ905291C, UPC Number: 019532706254. d. Model Number: DYNJ61957A, UPC Number: 019348969907. e. Model Number: DYNJ36600F, UPC Number: 088994255256. f. Model Number: DYNJV0275J, UPC Number: 019348926312; Model Number: DYNJV0275K, UPC Number: 019348926312; Model Number: DYNJV0275L, UPC Number: 019348926312; Model Number: DYNJV0275M, UPC Number: 019532701862. g. Model Number: DYNJ69682, UPC Number: 019348996892. h. Model Number: CDS840493F, UPC Number: 019348964363. i. Model Number: DYNJ24272C, UPC Number: 019348962022. j. Model Number: DYNJ905290D, UPC Number: 019532706253. k. Model Number: DYNDC3038, UPC Number: 019348949360. l. Model Number: DYNJ81636, UPC Number: 019532712918; Model Number: DYNJ81636A, UPC Number: 019532724491. m. Model Number: DYNJ83051, UPC Number: 019532724528. n. Model Number: DYNJ40728D, UPC Number: 019532734836. o. Model Number: DYNJ40728A, UPC Number: 088827704690; Model Number: DYNJ40728B, UPC Number: 019348997028; Model Number: DYNJ40728C, UPC Number: 019532703746. p. Model Number: DYNJ83462, UPC Number: 019532726814. q. Model Number: DYNJ64143B, UPC Number: 019532727958; Model Number: DYNJ905219B, UPC Number: 019348992403; Model Number: DYNJ905219C, UPC Number: 019532712693; Model Number: DYNJ905219D, UPC Number: 019532715487; Model Number: DYNJ905219F, UPC Number: 019532733532; Model Number: DYNJ906341D, UPC Number: 019532702148; Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975, UPC Number:019348996560; Model Number: DYNJ907975B, UPC Number: 019532737629; Model Number: DYNJ908096, UPC Number: 019348997407. r. Model Number: DYNJ82570, UPC Number: 019532719806. s. Model Number: DYNJ52093J, UPC Number: 019348998856; Model Number: DYNJ62218B, UPC Number: 019348996016; Model Number: DYNJ66184A, UPC Number: 019348991193; Model Number: DYNJ66184B, UPC Number: 019532703433; Model Number: DYNJ67178A, UPC Number: 019532702787; Model Number: DYNJ69443A, UPC Number: 019532702654; Model Number: DYNJ69443B, UPC Number: 019532708906; Model Number: DYNJ69443D, UPC Number: 019532727023; Model Number: DYNJ69489A, UPC Number: 019532722704; Model Number: DYNJ81033, UPC Number: 019532708298; Model Number: DYNJ81605, UPC Number: 019532712388; Model Number: DYNJ82477, UPC Number: 019532719722. t. Model Number: DYNJ64499B, UPC Number: 019348996109; Model Number: DYNJ64499, UPC Number: 019532722644; Model Number: DYNJ69167A, UPC Number: 019532708351; Model Number: DYNJ69167C, UPC Number: 019532734312. u. Model Number: DYNJ67340, UPC Number: 019348990107. v. Model Number: DYNJ903457D, UPC Number: 019348967091. w. Model Number: DYNJ40077F, UPC Number: 019532717581. x. Model Number: CDS983147F, UPC Number: 019348963379; Model Number: CDS983147I, UPC Number: 019532707551. y. Model Number: CDS984642, UPC Number: 088438988292. z. Model Number: DYNJ907339, UPC Number: 019348939732. aa. Model Number: DYNJ64861A, UPC Number: 019532705363. bb. Model Number: DYNJ64862B, UPC Number: 019532705370. cc. Model Number: DYNJ906878A, UPC Number: 019348939130; Model Number: DYNJ9372030F, UPC Number: 019348966807; Model Number: DYNJ9372030G, UPC Number: 019532702543. dd. Model Number: CDS985384C, UPC Number: 088994296218. ee. Model Number: DYNJ0408782AA, UPC Number: 019532711581; Model Number: DYNJ53827, UPC Number: 088994244401; Model Number: DYNJ59036B, UPC Number: 019348967227; Model Number: DYNJ59036C, UPC Number: 019348988162; Model Number: DYNJ59036D, UPC Number: 019532700347; Model Number: DYNJ59036F, UPC Number: 019532727293. ff. Model Number: DYNJ68389, UPC Number: 019348944114; Model Number: DYNJ68389A, UPC Number: 019348991219. gg. Model Number: DYNJV0177AG, UPC Number: 019532711235. hh. Model Number: DYNJV0177AG, UPC Number: 019532711235. ii. Model Number: DYNJ908121A, UPC Number: 019532700057; Model Number: DYNJ908121B, UPC Number: 019532709571. jj. Model Number: DYNJ903072R, UPC Number: 019348983405. kk. Model Number: DYNJ41195D, UPC Number: 019348931425. ll. Model Number: DYNJ0429185K, UPC Number: 019348956435; Model Number: DYNJ0429185M, UPC Number: 019532737135. mm. Model Number: DYNJ66254A, UPC Number: 019348981897. nn. Model Number: DYNJ59968, UPC Number: 088827779132. oo. Model Number: DYNJ905516C, UPC Number: 019348996712; Model Number: DYNJ905516D, UPC Number: 019532714783; Model Number: DYNJ905516F, UPC Number: 019532724757. pp. Model Number: DYNJ906351B, UPC Number: 019348981671; Model Number: DYNJ906351D, UPC Number: 019532716157. qq. Model Number: DYNJ905640A, UPC Number: 019532703918. rr. Model Number: DYNJ0810062AI, UPC Number: 019348956435; Model Number: DYNJ0810062AJ, UPC Number: 019532732546; Model Number: DYNJ39488G, UPC Number: 019348938377; Model Number: DYNJ66190A, UPC Number: 019348991300; Model Number: DYNJ66190B, UPC Number: 019532703432; Model Number: DYNJ66190C, UPC Number: 019532734200; Model Number: DYNJ80346A, UPC Number: 019532716625. ss. Model Number: DYNJ57646C, UPC Number: 019532728713. tt. Model Number: DYNJ81369, UPC Number: 019532711530. uu. Model Number: DYNJ44927F, UPC Number: 019348976680. vv. Model Number: CDS984764F, UPC Number: 088994296945; Model Number: DYNJ901745K, UPC Number: 019348948223. ww. Model Number: DYNJ57735F, UPC Number: 019348962970. xx. Model Number: DYNJ59830A, UPC Number: 019348957023. yy. Model Number: DYNJ62379A, UPC Number: 019532719663. zz. Model Number: DYNJC9258G, UPC Number: 019532724550. aaa. Model Number: CDS983202F, UPC Number: 019348933525; Model Number: CDS983202G, UPC Number: 019348949077; Model Number: CDS983202I, UPC Number: 019532716467. bbb. Model Number: DYNJ906108A, UPC Number: 019348944363; Model Number: DYNJ906108B, UPC Number: 019532704117; Model Number: DYNJ906108C, UPC Number: 019532711827. ccc. Model Number: DYNJ65710A, UPC Number: 019348993865. ddd. Model Number: CDS985395D, UPC Number: 019348985971. eee. Model Number: DYNJ83432, UPC Number: 019532726653. fff. Model Number: DYNJ64506A, UPC Number: 019348997106. ggg. Model Number: DYNJ46359C, UPC Number: 088994253711; Model Number: DYNJ46359D, UPC Number: 019348996137. hhh. Model Number: DYNJ905291C, UPC Number: 019532706254. iii. Model Number: CDS840493F, UPC Number: 019348964363. jjj. Model Number: CDS840493F, UPC Number: 019348964363. kkk. Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975A, UPC Number: 019532715507. lll. Model Number: DYNJ69443C, UPC Number: 019532712973. mmm. Model Number: DYNJ57646B, UPC Number: 019348982850. nnn. Model Number: DYNJ64964B, UPC Number: 019532707581. ooo. Model Number: DYNJ59028A, UPC Number: 019348973659. ppp. Model Number: DYNJ907552A, UPC Number: 019532716605. qqq. Model Number: DYNJ56904, UPC Number: 088994269345. rrr. Model Number: DYNJ63209, UPC Number: 019348972788. sss. Model Number: DYNJ67487B, UPC Number: 019532716614. ttt. Model Number: DYNJ905495F, UPC Number: 019348992493. uuu. Model Number: DYKMBNDL22B, UPC Number: 019532705026. vvv. Model Number: DYNJ905884A, UPC Number: 019348979544. www. Model Number: DYNJ81610, UPC Number: 019532712394. xxx. Model Number: DYNJ54286A, UPC Number: 088994276549. yyy. Model Number: CDS984241M, UPC Number: 019532716563. zzz. Model Number: DYNJ23697N, UPC Number: 019348949845. aaaa. Model Number: DYNJ55836B, UPC Number: 019348995117. bbbb. Model Number: DYNJ63341C, UPC Number: 019532708612. cccc. Model Number: DYNJ48365, UPC Number: 088827759459. dddd. Model Number: DYNJ69422, UPC Number: 019348993754. eeee. Model Number: DYNJ905744C, UPC Number: 019532716231. ffff. Model Number: CDS984764G, UPC Number: 019348945029. gggg. Model Number: DYNJ81642, UPC Number: 019532712966. hhhh. Model Number: DYNJ68404A, UPC Number: 019348991392. iiii. Model Number: DYNJ65048, UPC Number: 019348924286. jjjj. Model Number: DYNJ43085A, UPC Number: 019348960034. kkkk. Model Number: DYNJ64261A, UPC Number: 019348932556. llll. Model Number: DYNJ42976, UPC Number: 088827701914. mmmm. Model Number: DYNJ907914, UPC Number: 019348994367; Model Number: DYNJ907914A, UPC Number: 019532714952; Model Number: DYNJ907914B, UPC Number: 019532718060; Model Number: DYNJ907914C, UPC Number: 019532732943. nnnn. Model Number: DYNJ57595A, UPC Number: 019348962215. oooo. Model Number: DYNJ0037939B, UPC Number: 019532703127. pppp. Model Number: DYNJ52024, UPC Number: 088994223335. qqqq. Model Number: DYNJ51968D, UPC Number: 019348967831. rrrr. Model Number: DYNJ56235, UPC Number: 088994262155. ssss. Model Number: DYNJ61247, UPC Number: 019348955170. tttt. Model Number: DYNJ907552A, UPC Number: 019532716605. uuuu. Model Number: DYNJ67517A, UPC Number: 019348946219. vvvv. Model Number: PHS41732B, UPC Number: 019348978481. wwww. Model Number: DYNJ55669C, UPC Number: 019348944785; Model Number: DYNJ55669D, UPC Number: 019532701301. xxxx. Model Number: DYNJ57449C, UPC Number: 019348947184; Model Number: DYNJ57449D, UPC Number: 019348987229; Model Number: DYNJ57449F, UPC Number: 019348993920; Model Number: DYNJ57449G, UPC Number: 019532706488. yyyy. Model Number: DYNJ49931I, UPC Number: 019348993921. zzzz. Model Number: DYNJ54803B, UPC Number: 019348963378; Model Number: DYNJ54803C, UPC Number: 019348920261.

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.

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.

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