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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 15, 2023
Date PostedAugust 03, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2319-2023
Recall Event ID 92399
Product Classification General surgery tray - Product Code LRO
ProductCustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B; d. AAA PACK, Model Number: DYNJ44918C; e. AAA PACK - TEAM 3, Model Number: DYNJ44847G; f. ABLATION PACK, Model Number: DYNJ62540, DYNJ64068; g. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658A; h. ACCESS KIT, Model Number: DYNDH1159A; i. ACCESS PACK, Model Number: DYNJ69017; j. ACCESSORY KIT, Model Number: DYNJ901348D; k. ADULT CORONARY PACK, Model Number: DYNJV0275F; l. ADULT CVC MAX BARRIER KIT-LF, Model Number: DYNJ38714B; m. ALL PURPOSE TRAY FOAKS, Model Number: DYNJ63576, DYNJ63576A; n. AMINO KIT; Model Number: DYNDH1649; o. AMNIOCENTESIS TRAY, Model Number: DYNDH1420; p. ANGIO STANDARD PACK-LF, Model Number: DYNJ0370436Q; q. ANGIO TRAY, Model Number: DYNJ23438J; r. ANGIOGRAM PACK, Model Number: DYNJ47004B; s. ANGIOGRAM TRAY, Model Number: DYNJ33638I; t. ANGIO-VASCULAR, Model Number: DYNJ24272B; u. ARTERIAL PACK, Model Number: DYNJ51340D; v. ARTERIO-VENOUS CDS, Model Number: CDS984186C; w. ASPIRATION TRAY, Model Number: DYNDH1467; x. ASPIRE EXACT TRAY, Model Number: DYNJRA1716, DYNJRA1716A; y. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299L; z. BASIC PACK, Model Number: DYNJ37460A, DYNJ42691, DYNJ52122B, DYNJ52171, DYNJ55456, DYNJ55457, DYNJ81343; aa. BASIC PROCEDURE PACK, Model Number: DYNJ53122B; bb. BASIC VEIN PACK, Model Number: DYNJ58650; cc. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; dd. BGMC LIVER TRANSPLANT, Model Number: DYNJ9664651D; ee. BIOPSY TRAY, Model Number: DYNDH1340; ff. BLOCK KIT, Model Number: DYNJRA1145; gg. BLOCK SUPPLIES NDL CNTR, Model Number: DYNJRA1755; hh. BREAST ULTRASOUND PROCEDURE TR, Model Number: DYNDL1596A; ii. BUNDLE KIT, Model Number: DYNJ49737B, DYNJ49737C; jj. C V MAJOR PACK, Model Number: DYNJ64861; kk. CABG UNIVERSITY HOSP PACK-LF, Model Number: DYNJ0375705L; ll. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640; mm. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; nn. CHP TRANSPLANT CDS, Model Number: CDS983082I, CDS983082J; oo. CLINIC PACK, Model Number: DYNJRA1578; pp. CLOSURE CDS, Model Number: CDS983704G, CDS983704I; qq. CLOSURE FAST PACK UNIV, Model Number: DYNJ53482A; rr. CLOSURE PACK, Model Number: DYNJ54437A, DYNJ54437C, DYNJ57514, DYNJ60804; ss. CLOSURE PACK-LF, Model Number: DYNJ0807503M; tt. CLOSURE PROCEDURE, Model Number: DYNJ59206; uu. CLOSURE PROCEDURE PACK, Model Number: DYNJ66741; vv. CLOSURE PROCEDURE PKSJO-LF, Model Number: DYNJ35409F; ww. CLOT RETRIEVAL PACK, Model Number: DYNJ56140B; xx. CLOVIS MINOR IR PROCEDURE-LF, Model Number: DYNJ61067; yy. COMMANDO PACK MSH-LF, Model Number: DYNJ48525D; zz. CONTINUOUS BLOCK, Model Number: DYNJRA0960B; aaa. COPS PROCEDURE PACK-LF, Model Number: DYNJ68923A; bbb. CRMC MINOR IR PROCEDURE PK-LF, Model Number: DYNJ61099, DYNJ61099A; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710; ddd. CV ACCESS PACK WRO-LF, Model Number: DYNJ41875B; eee. CV CDS, Model Number: CDS985395C; fff. CV MINOR CDS, Model Number: CDS984100T; ggg. CV PACK, Model Number: DYNJ45074B; hhh. CVC PACK, Model Number: DYNJ44010; iii. CVL PACK, Model Number: DYNJ00281N; jjj. CVOR CDS-LF, Model Number: CDS840198V; kkk. CYSTO PACK SMGH-LF, Model Number: DYNJ41915A; lll. DAVIES PHALLOPLASTY PACK, Model Number: DYNJ52185F; mmm. DAVINCI, Model Number: DYNJ906543A; nnn. DBD-BASIC PACK, Model Number: DYNJ55458; ooo. DBD-BIOPSY PACK-LF, Model Number: DYNJ0747885F; ppp. DBD-DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069M; qqq. DBD-ECMO MODULE PACK, Model Number: DYNJ55669F; rrr. DBD-EVLA PACK, Model Number: DYNJ6
Code Information All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ECVC4740, UPC Number: 10653160335214. b. Model Number: DYNJ36212C, UPC Number: 088994288566. c. Model Number: DYNJ905651, UPC Number: 088827778831; Model Number: DYNJ905651A, UPC Number: 019348968651; Model Number: DYNJ905651B, UPC Number: 019348992506. d. Model Number: DYNJ44918C, UPC Number: 019348976679. e. Model Number: DYNJ44847G, UPC Number: 019348962983. f. Model Number: DYNJ62540, UPC Number: 019348966647; Model Number: DYNJ64068, UPC Number: 019348978313. g. Model Number: DYNJ53658A, UPC Number: 088994268440. h. Model Number: DYNDH1159A, UPC Number: 088994288165. i. Model Number: DYNJ69017, UPC Number: 019348987815. j. Model Number: DYNJ901348D, UPC Number: 019348959468. k. Model Number: DYNJV0275F, UPC Number: 019348926312. l. Model Number: DYNJ38714B, UPC Number: 088994260193. m. Model Number: DYNJ63576, UPC Number: 019348976954; Model Number: DYNJ63576A, UPC Number: 019348942925. n. Model Number: DYNDH1649, UPC Number: 019348994436. o. Model Number: DYNDH1420, UPC Number: 019348936044. p. Model Number: DYNJ0370436Q, UPC Number: 088827777928. q. Model Number: DYNJ23438J, UPC Number: 019348956435. r. Model Number: DYNJ47004B, UPC Number: 088827775429. s. Model Number: DYNJ33638I, UPC Number: 019348956435. t. Model Number: DYNJ24272B, UPC Number: 019348956435. u. Model Number: DYNJ51340D, UPC Number: 019348956981. v. Model Number: CDS984186C, UPC Number: 088994295750. w. Model Number: DYNDH1467, UPC Number: 019348943966. x. Model Number: DYNJRA1716, UPC Number: 019348926312; Model Number: DYNJRA1716A, UPC Number: 019348989641. y. Model Number: DYNJC9299L, UPC Number: 019348926312. z. Model Number: DYNJ37460A, UPC Number: 088827756043; Model Number: DYNJ42691, UPC Number: 088827700350; Model Number: DYNJ52122B, UPC Number: 019348993530; Model Number: DYNJ52171, UPC Number: 088994224347; Model Number: DYNJ55456, UPC Number: 088994254844; Model Number: DYNJ55457, UPC Number: 088994254846; Model Number: DYNJ81343, UPC Number: 019532711306. aa. Model Number: DYNJ53122B, UPC Number: 019348932122. bb. Model Number: DYNJ58650, UPC Number: 088994287665. cc. Model Number: MNS7695A, UPC Number: 065316034345. dd. Model Number: DYNJ9664651D, UPC Number: 019348939642. ee. Model Number: DYNDH1340, UPC Number: 088994289450. ff. Model Number: DYNJRA1145, UPC Number: 088994292854. gg. Model Number: DYNJRA1755, UPC Number: 019348984284. hh. Model Number: DYNDL1596A, UPC Number: 088438992650. ii. Model Number: DYNJ49737B, UPC Number: 019348939440; Model Number: DYNJ49737C, UPC Number: 019532723588. jj. Model Number: DYNJ64861, UPC Number: 019348922377. kk. Model Number: DYNJ0375705L, UPC Number: 019348954413. ll. Model Number: DYNJ905640, UPC Number: 019348952767. mm. Model Number: TRICHT1120, UPC Number: 065316031829. nn. Model Number: CDS983082I, UPC Number: 088994277286; Model Number: CDS983082J, UPC Number: 019348967451. oo. Model Number: DYNJRA1578, UPC Number: 019348927278. pp. Model Number: CDS983704G, UPC Number: 088994280844; Model Number: CDS983704I, UPC Number: 019348985455. qq. Model Number: DYNJ53482A, UPC Number: 088994291731. rr. Model Number: DYNJ54437A, UPC Number: 088994256796; Model Number: DYNJ54437C, UPC Number: 019348924397; Model Number: DYNJ57514, UPC Number: 088994274784; Model Number: DYNJ60804, UPC Number: 019348953278. ss. Model Number: DYNJ0807503M, UPC Number: 088994209173. tt. Model Number: DYNJ59206, UPC Number: 088827776557. uu. Model Number: DYNJ66741, UPC Number: 019348937494. vv. Model Number: DYNJ35409F, UPC Number: 088827777124. ww. Model Number: DYNJ56140B, UPC Number: 019348954767. xx. Model Number: DYNJ61067, UPC Number: 019348954222. yy. Model Number: DYNJ48525D, UPC Number: 019348975077. zz. Model Number: DYNJRA0960B, UPC Number: 019348926312. aaa. Model Number: DYNJ68923A, UPC Number: 019532707079. bbb. Model Number: DYNJ61099, UPC Number: 019348954424; Model Number: DYNJ61099A, UPC Number: 019348946396. ccc. Model Number: DYNJ65710, UPC Number: 019348928508. ddd. Model Number: DYNJ41875B, UPC Number: 019348956307. eee. Model Number: CDS985395C, UPC Number: 088994286348. fff. Model Number: CDS984100T, UPC Number: 019348939994. ggg. Model Number: DYNJ45074B, UPC Number: 088994284064. hhh. Model Number: DYNJ44010, UPC Number: 088827707945. iii. Model Number: DYNJ00281N, UPC Number: 019348956435. jjj. Model Number: CDS840198V, UPC Number: 088994295567. kkk. Model Number: DYNJ41915A, UPC Number: 088827756881. lll. Model Number: DYNJ52185F, UPC Number: 019348936871. mmm. Model Number: DYNJ906543A, UPC Number: 019348981803. nnn. Model Number: DYNJ55458, UPC Number: 088994254845. ooo. Model Number: DYNJ0747885F, UPC Number: 019348956435. ppp. Model Number: DYNJ0426069M, UPC Number: 019532720575. qqq. Model Number: DYNJ55669F, UPC Number: 019532731371. rrr. Model Number: DYNJ66258A, UPC Number: 019532719423. sss. Model Number: DYNJ66620A, UPC Number: 019348991424. ttt. Model Number: CDS984379D, UPC Number: 088994272434. uuu. Model Number: DYNJ0604540Q, UPC Number: 019348983968. vvv. Model Number: DYNJ38563O, UPC Number: 019348925174. www. Model Number: DYNJ905936B, UPC Number: 019348942281. xxx. Model Number: DYNJ906902A, UPC Number: 019348997120. yyy. Model Number: DYNJ900337A, UPC Number: 088994219386. zzz. Model Number: DYNJ58160, UPC Number: 088994282864. aaaa. Model Number: DYNDA2769, UPC Number: 019348945716. bbbb. Model Number: DYNJ68923, UPC Number: 019348985856. cccc. Model Number: CDS984329J, UPC Number: 088994286535. dddd. Model Number: CDS984327I, UPC Number: 088994286537. eeee. Model Number: DYNJ33546K, UPC Number: 019348991717. ffff. Model Number: DYNJ908752, UPC Number: 019532717136. gggg. Model Number: DYNJ53845A, UPC Number: 088994253675. hhhh. Model Number: DYNJ68959, UPC Number: 019348986686. iiii. Model Number: DYNJ48454, UPC Number: 088827759528. jjjj. Model Number: DYNJ60128A, UPC Number: 019348954451. kkkk. Model Number: DYNJ907279, UPC Number: 019348938641. llll. Model Number: DYNJ31934D, UPC Number: 019532707150. mmmm. Model Number: DYNDA2011B, UPC Number: 019348953302. nnnn. Model Number: DYNJ59377, UPC Number: 088827773629. oooo. Model Number: DYNJRA0585, UPC Number: 088827758069. pppp. Model Number: DYNJ83438, UPC Number: 019532726659. qqqq. Model Number: DYNJ35457B, UPC Number: 019348956435. rrrr. Model Number: DYNJ905702B, UPC Number: 019348958721. ssss. Model Number: DYNJ66867, UPC Number: 019348939016. tttt. Model Number: DYNJ60669A, UPC Number: 019348920588; Model Number: DYNJ60669B, UPC Number: 019348987734; Model Number: DYNJ63156A, UPC Number: 019348985231; Model Number: DYNJ64964A, UPC Number: 019348935382. uuuu. Model Number: DYNJ82575, UPC Number: 019532719811. vvvv. Model Number: DYNJ0426069M, UPC Number: 019532720575. wwww. Model Number: DYNJRA1226A, UPC Number: 019348956964. xxxx. Model Number: DYNJ66283A, UPC Number: 019348940904. yyyy. Model Number: DYNJ907552, UPC Number: 019348949583. zzzz. Model Number: DYNJ0351069, UPC Number: 088994205905.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer Reason
for Recall		Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.
Quantity in Commerce83,541 kits
DistributionWorldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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