Class II FDA device recall · Z-2302-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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: DYNJ908074B; aaa. SCA VEIN PACK, Model Number: DYNJ63817; bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F; ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521; ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418; eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314; fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I; ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C; hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918; iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563; jjj. STROKE KIT, Model Number: DYNJ80506; kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A; lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B; mmm. SVMMC CAROTID PACK, Model Number: DYNJ43861F; nnn. SVMMC AV

Why it was recalled

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / 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: 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.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2302-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-15

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2302-2023 · Source: openFDA enforcement.