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RecallWatchMedical Device Safety
Class IIOngoingZ-1444-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) A & A KNEE PACK-LF

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Apr 2, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pack Number DYNJ63532; 7) BASIC PACK, Pack Number DYNJ81702; 8) BASIC PACK, Pack Number DYNJ36595D; 9) BASIC PACK, Pack Number DYNJ69250A; 10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C; 11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A; 12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A; 13) CABG PACK, Pack Number DYNJ20114Q; 14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L; 15) CHEST PACK SC-LF, Pack Number DYNJ38051F; 16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B; 17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B; 18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C; 19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B; 20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385; 21) CT BASIC PACK, Pack Number DYNJ51617A; 22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I; 23) CYSTO, Pack Number DYNJ24351D; 24) CYSTO PACK, Pack Number DYNJ62359A; 25) DAVINCI PACK, Pack Number DYNJ04113C; 26) DUPYTRENS PACK, Pack Number DYNJ60496; 27) EH PACEMAKER PACK, Pack Number DYNJ55734C; 28) EVLT PACK, Pack Number DYNJ45997C; 29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G; 30) GENERAL BASIC PACK, Pack Number DYNJ82039; 31) GENERAL PURPOSE CV, Pack Number DYNJ904395F; 32) GENERAL UTILITY PACK, Pack Number DYNJ45093B; 33) HP DEVICE-LF, Pack Number DYNJ62255A; 34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B; 35) IR PACK, Pack Number DYNJ32080L; 36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857; 37) IR TABLE PACK II, Pack Number DYNJ56298B; 38) JVL-PACK TUNNELED, Pack Number DYNJ66065; 39) LITHOTOMY PACK, Pack Number DYNJ66490B; 40) LITHOTOMY PACK, Pack Number DYNJ65380A; 41) LOOP RECORDER PACK, Pack Number DYNJ53221B; 42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A; 43) MAJOR BASIN PACK, Pack Number DYNJ67484A; 44) MAJOR PACK, Pack Number DYNJ51996; 45) MAJOR PACK-LF, Pack Number DYNJ24599I; 46) MINI PACK, Pack Number DYNJ52305D; 47) MINI SET UP KIT, Pack Number DYNJ81562; 48) MINOR BASIN, Pack Number DYNJ43021B; 49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286; 50) MINOR PACK-LF, Pack Number DYNJ0551383P; 51) MINOR PK-LF, Pack Number DYNJ21408D; 52) MINOR WAKEFIELD, Pack Number DYNJ58872A; 53) MYELOGRAM TRAY, Pack Number DYNDH1775A; 54) OB PACK, Pack Number DYNJ32216B; 55) OPEN STERILE PACK, Pack Number DYNJ62104A; 56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B; 57) PACK URO-BASIC, Pack Number DYNJ38246A; 58) PACK,LTD BODY SSP, Pack Number DYNJ65488B; 59) PARACENTESIS, Pack Number DYNJ44505B; 60) PBMS NECK PACK-LF, Pack Number DYNJ64961A; 61) PEDI MAJOR PACK, Pack Number DYNJ40062K; 62) PEDI PK-LF, Pack Number DYNJ21240J; 63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B; 64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B; 65) PK, GEN-MINOR, Pack Number DYNJ59461C; 66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B; 67) PK, URO-CYSTO-MH, Pack Number DYNJ62501; 68) PK-GEN-BASIC, Pack Number DYNJ42382B; 69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B; 70) PODIATRY PACK, Pack Number DYNJ37297D; 71) PST PACK, Pack Number DYNJ62666; 72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J; 73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A; 74) SHUNT PACK-LF, Pack Number PHS967363W; 75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242; 76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X; 77) STANDARD ICL PACK-LF, Pack Number PHS895675B; 78) T & A PK-LF, Pack Number DYNJT2408C; 79) THORACIC PACK SHD, Pack Number DYNJ68416C; 80) TONSIL PACK-LF, Pack Number DYNJ0553334I; 81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I; 82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M; 83) VASECTOMY PACK, Pack Number DYNJ65326; 84) VASECTOMY PACK,

Lot / code information

Lot #
22JBC557Z; 2) Pack Number DYNJ56987B: UDI/DI 10889942868193 (each) 40889942868194 (case)
Lot #
21EBN072A; 3) Pack Number PHS170994005A: UDI/DI 10888277754379 (each) 40888277754370 (case)
Lot #
21IMG402A; 4) Pack Number DYNJ54836B: UDI/DI 10193489574128 (each) 40193489574129 (case)
Lot #
21BBH689A; 5) Pack Number DYNJ58678A: UDI/DI 10888277781207 (each) 40888277781208 (case)
Lot #
21GMF677A; 6) Pack Number DYNJ63532: UDI/DI 10193489748468 (each) 40193489748469 (case)
Lot #
22CMB574A; 7) Pack Number DYNJ81702: UDI/DI 10195327135447 (each) 40195327135448 (case)
Lot #
23CBF695A; 8) Pack Number DYNJ36595D: UDI/DI 10193489928976 (each) 40193489928977 (case)
Lot #
23CBL653A; 9) Pack Number DYNJ69250A: UDI/DI 10195327142315 (each) 40195327142316 (case)
Lot #
23HME051A; 10) Pack Number DYNJ50470C: UDI/DI 10889942922611 (each) 40889942922612 (case)
Lot #
23FME520A; 11) Pack Number DYNJ0115839A: UDI/DI 10193489901764 (each) 40193489901765 (case)
Show 77 more code fields
Lot #
23FME450A; 12) Pack Number PHS396134006A: UDI/DI 10889942694303 (each) 40889942694304 (case)
Lot #
23DDA331A; 13) Pack Number DYNJ20114Q: UDI/DI 10193489549249 (each) 40193489549240 (case)
Lot #
22JBF822Z; 14) Pack Number DYNJ0375705L: UDI/DI 10193489544138 (each) 40193489544139 (case)
Lot #
22GBP901M; 15) Pack Number DYNJ38051F: UDI/DI 10193489909319 (each) 40193489909310 (case)
Lot #
23EMC825A; 16) Pack Number DYNJ0161358B: UDI/DI 10889942213269 (each) 40889942213260 (case)
Lot #
23DDA354A; 17) Pack Number DYNJ50844B: UDI/DI 10889942883271 (each) 40889942883272 (case)
Lot #
22GMD340Z; 18) Pack Number DYNJ46776C: UDI/DI 10889942893218 (each) 40889942893219 (case)
Lot #
21BBE822A; 19) Pack Number DYNJ40640B: UDI/DI 10193489292145 (each) 40193489292146 (case)
Lot #
21IME326A; 20) Pack Number DYNJ39385: UDI/DI 10884389765067 (each) 40884389765068 (case)
Lot #
21IMD121A; 21) Pack Number DYNJ51617A: UDI/DI 10889942448616 (each) 40889942448617 (case)
Lot #
20LKB440A; 22) Pack Number DYNJ06672I: UDI/DI 10889942725830 (each) 40889942725831 (case)
Lot #
23BBU700A; 23) Pack Number DYNJ24351D: UDI/DI 10193489738841 (each) 40193489738842 (case)
Lot #
21LBD180A; 24) Pack Number DYNJ62359A: UDI/DI 10193489202571 (each) 40193489202572 (case)
Lot #
20AKB925A; 25) Pack Number DYNJ04113C: UDI/DI 10889942934102 (each) 40889942934103 (case)
Lot #
21EBP303A; 26) Pack Number DYNJ60496: UDI/DI 10193489506174 (each) 40193489506175 (case)
Lot #
22GBU071Z; 27) Pack Number DYNJ55734C: UDI/DI 10889942779093 (each) 40889942779094 (case)
Lot #
20FMA632A; 28) Pack Number DYNJ45997C: UDI/DI 10889942684366 (each) 40889942684367 (case)
Lot #
23GBF502A; 29) Pack Number DYNJ51799G: UDI/DI 10193489475944 (each) 40193489475945 (case)
Lot #
22CDB465A; 30) Pack Number DYNJ82039: UDI/DI 10195327163877 (each) 40195327163878 (case)
Lot #
23EBE702A; 31) Pack Number DYNJ904395F: UDI/DI 10193489701333 (each) 40193489701334 (case)
Lot #
22FBS141Z; 32) Pack Number DYNJ45093B: UDI/DI 10195327044213 (each) 40195327044214 (case)
Lot #
23BLB075A; 33) Pack Number DYNJ62255A: UDI/DI 10193489276671 (each) 40193489276672 (case)
Lot #
22GBU775A; 34) Pack Number DYNJ42231B: UDI/DI 10193489948165 (each) 40193489948166 (case)
Lot #
21HMB550A; 35) Pack Number DYNJ32080L: UDI/DI 10193489691900 (each) 40193489691901 (case)
Lot #
21BBJ386A; 36) Pack Number DYNJ64857: UDI/DI 10193489223361 (each) 40193489223362 (case)
Lot #
21IME211A; 37) Pack Number DYNJ56298B: UDI/DI 10193489415902 (each) 40193489415903 (case)
Lot #
21HME360A; 38) Pack Number DYNJ66065: UDI/DI 10193489319187 (each) 40193489319188 (case)
Lot #
23LMG850A; 39) Pack Number DYNJ66490B: UDI/DI 10195327472962 (each) 40195327472963 (case)
Lot #
23HMC391A; 40) Pack Number DYNJ65380A: UDI/DI 10195327418083 (each) 40195327418084 (case)
Lot #
23LMF918A; 41) Pack Number DYNJ53221B: UDI/DI 10193489922288 (each) 40193489922289 (case)
Lot #
23GMC211A; 42) Pack Number DYNJ48058A: UDI/DI 10193489325669 (each) 40193489325660 (case)
Lot #
21JMH979A; 43) Pack Number DYNJ67484A: UDI/DI 10195327020743 (each) 40195327020744 (case)
Lot #
23DME735A; 44) Pack Number DYNJ51996: UDI/DI 10889942233205 (each) 40889942233206 (case)
Lot #
21BBG178A; 45) Pack Number DYNJ24599I: UDI/DI 10193489315141 (each) 40193489315142 (case)
Lot #
21IMH674A; 46) Pack Number DYNJ52305D: UDI/DI 10195327028572 (each) 40195327028573 (case)
Lot #
22JBU974A; 47) Pack Number DYNJ81562: UDI/DI 10195327122539 (each) 40195327122530 (case)
Lot #
22JBW597A; 48) Pack Number DYNJ43021B: UDI/DI 10193489258851 (each) 40193489258852 (case)
Lot #
21GMC689A; 49) Pack Number DYNJ69286: UDI/DI 10193489922189 (each) 40193489922180 (case)
Lot #
23IMF699A; 50) Pack Number DYNJ0551383P: UDI/DI 10889942962143 (each) 40889942962144 (case)
Lot #
21GMB523A; 51) Pack Number DYNJ21408D: UDI/DI 10195327053642 (each) 40195327053643 (case)
Lot #
21LMF738A; 52) Pack Number DYNJ58872A: UDI/DI 10193489751871 (each) 40193489751872 (case)
Lot #
23JBW564A; 53) Pack Number DYNDH1775A: UDI/DI 10195327362218 (each) 40195327362219 (case)
Lot #
23LBM803Z; 54) Pack Number DYNJ32216B: UDI/DI 10193489546101 (each) 40193489546102 (case)
Lot #
21BBF074A; 55) Pack Number DYNJ62104A: UDI/DI 10193489763713 (each) 40193489763714 (case)
Lot #
23FBO390A; 56) Pack Number DYNJ60124B: UDI/DI 10193489982855 (each) 40193489982856 (case)
Lot #
21LMG031A; 57) Pack Number DYNJ38246A: UDI/DI 10884389757772 (each) 40884389757773 (case)
Lot #
23BBQ828A; 58) Pack Number DYNJ65488B: UDI/DI 10193489443646 (each) 40193489443647 (case)
Lot #
23LMG039A; 59) Pack Number DYNJ44505B: UDI/DI 10889942379248 (each) 40889942379249 (case)
Lot #
20BDB430A; 60) Pack Number DYNJ64961A: UDI/DI 10193489416039 (each) 40193489416030 (case)
Lot #
23IMF244A; 61) Pack Number DYNJ40062K: UDI/DI 10195327493325 (each) 40195327493326 (case)
Lot #
23LMF453A; 62) Pack Number DYNJ21240J: UDI/DI 10889942931378 (each) 40889942931379 (case)
Lot #
21IMH809A; 63) Pack Number DYNJ51725B: UDI/DI 10193489538731 (each) 40193489538732 (case)
Lot #
21KBJ357A; 64) Pack Number DYNJ55355B: UDI/DI 10195327173784 (each) 40195327173785 (case)
Lot #
23CBN280A; 65) Pack Number DYNJ59461C: UDI/DI 10195327510107 (each) 40195327510108 (case)
Lot #
24ABA333Z; 66) Pack Number DYNJ43754B: UDI/DI 10193489808964 (each) 40193489808965 (case)
Lot #
20HMD448A; 67) Pack Number DYNJ62501: UDI/DI 10193489664829 (each) 40193489664820 (case)
Lot #
21LBB961A; 68) Pack Number DYNJ42382B: UDI/DI 10195327253288 (each) 40195327253289 (case)
Lot #
23LMG144A; 69) Pack Number DYNJ41824B: UDI/DI 10889942933488 (each) 40889942933489 (case)
Lot #
21LBW098A; 70) Pack Number DYNJ37297D: UDI/DI 10193489566567 (each) 40193489566568 (case)
Lot #
21JMH963A; 71) Pack Number DYNJ62666: UDI/DI 10193489679663 (each) 40193489679664 (case)
Lot #
23BBR333A; 72) Pack Number DYNJ0785683J: UDI/DI 10193489709315 (each) 40193489709316 (case)
Lot #
23LMD781A; 73) Pack Number DYNJ43502A: UDI/DI 10193489767858 (each) 40193489767859 (case)
Lot #
21BBI542A; 74) Pack Number PHS967363W: UDI/DI 10889942924561 (each) 40889942924562 (case)
Lot #
21LME249A; 75) Pack Number DYNJ30242: UDI/DI 10080196785834 (each) 40080196785835 (case)
Lot #
23LMG145A; 76) Pack Number DYNJ0129513X: UDI/DI 10195327511876 (each) 40195327511877 (case)
Lot #
23LMG678A; 77) Pack Number PHS895675B: UDI/DI 10193489418316 (each) 40193489418317 (case)
Lot #
22IMB409A; 78) Pack Number DYNJT2408C: UDI/DI 10884389367643 (each) 40884389367644 (case)
Lot #
21AMA394A; 79) Pack Number DYNJ68416C: UDI/DI 10195327341688 (each) 40195327341689 (case)
Lot #
23LBS810Z; 80) Pack Number DYNJ0553334I: UDI/DI 10193489513646 (each) 40193489513647 (case)
Lot #
23HME093A; 81) Pack Number DYNJ0375928I: UDI/DI 10193489544220 (each) 40193489544221 (case)
Lot #
23CBB970A; 82) Pack Number DYNJ0416615M: UDI/DI 10195327518936 (each) 40195327518937 (case)
Lot #
24DMC685Z; 83) Pack Number DYNJ65326: UDI/DI 10193489267587 (each) 40193489267588 (case)
Lot #
21LBG918A; 84) Pack Number DYNJ84729: UDI/DI 10195327407247 (each) 40195327407248 (case)
Lot #
23GBV524A; 85) Pack Number DYNJ57459A: UDI/DI 10888277759596 (each) 40888277759597 (case)
Lot #
22GBE165A; 86) Pack Number LINQKIT: 10193489709827 (each) 40193489709828 (case)
Lot #
22GDB223A; 87) Pack Number LINQKIT: 10193489709827 (each) 40193489709828 (case)
Lot #
23EDA439A

What the firm is doing

Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583

DistributionShow details

Worldwide distribution - US Nationwide and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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