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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

Agency Publication Date: July 12, 2023
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Affected Products

Product: MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A

GTIN 10889942851850, Batch Numbers: 2023011090, 2023011190, 2023011790, 2023012090, 2023012590, 2023020790, 2023022390, 2023022490

Lot Numbers:
Numbers
Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O

UDI/DI (EA) 10195327303969, UDI/DI (CS) 40195327303960; Lot Numbers: 23EBE453, 23CBW365

Lot Numbers:
Numbers
Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A

UDI/DI (EA) 10159327251772, UDI/DI (CS) 40195327251773; Lot Numbers: 23DDA761

Lot Numbers:
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Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L

UDI/DI (EA) (01)10195327286057, UDI/DI(CS) (01)40195327286058; Lot Numbers: 23EDA775, 23CDB962

Lot Numbers:
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Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A

UDI/DI (EA) (01)10193489799477, UDI/DI (01)40193489799478; Lot Numbers: 23CBS268

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Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB

a) Model Number DYNJ64572A, UDI/DI (EA) 10195327112554, (CS) 40195327112555, Lot Numbers:23FBA458, 23DBC239 ; b) Model Number VAL050EEPKB, UDI/DI (EA) 10195327267149, (CS) 40195327267149, Lot Numbers: 23EBA381, 23CBI693, 23BBE528

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Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655

a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799; Lot Numbers: 23EBK088; b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419; Lot Numbers: 23EBT802; c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367; Lot Numbers: 23DBP964, 23CBU228; d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752; Lot Numbers: 23EBT909, 23EBG098, 23DBB838; e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745; Lot Numbers: 23EBU894; f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986; Lot Numbers: 23EDC133; g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554; Lot Numbers: 23EBX487; h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922; Lot Numbers: 23EMB984; i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020; Lot Numbers: 23EBU158, 23DBF885; j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637; Lot Numbers: 23EBG175, 23DBH412; k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984; Lot Numbers: 23EME586, 23DME845; l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947; Lot Numbers: 23EBR893; m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067; Lot Numbers: 23DMF789, 23CMD239; n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100; Lot Numbers: 23EBM476; o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807; Lot Numbers: 23EBU903; p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225; Lot Numbers: 23EBV507, 23DBO770; q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509; Lot Numbers: 23DBR961; r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242; Lot Numbers: 23DBR962; s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235; Lot Numbers: 23CBH897; t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371; Lot Numbers: 23EDA972, 23EDA325; u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670; Lot Numbers: 23EBJ155, 23DBK433; v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157; Lot Numbers: 23CBW640; w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373; Lot Numbers: 23EME192, 23DMA865; x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557; Lot Numbers: 23CBV824; y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332; Lot Numbers: 23EBO198; z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357; Lot Numbers: 23BBD673; aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034; Lot Numbers: 23EBT837, 23DBS196; bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238; Lot Numbers: 23EBV315, 23CBR138; cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317; Lot Numbers: 23DBF769; dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348; Lot Numbers: 23DBF770; ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421; Lot Numbers: 23EDA478; ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130; Lot Numbers: 23EMF499; gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605; Lot Numbers: 23EDB706, 23EDB571, 23EDA974; hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701; Lot Numbers: 23EBG661, 23DBM833; ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695; Lot Numbers: 23DBE789, 23DBD483; jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503; Lot Numbers: 23DBO191; kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168; Lot Numbers: 23EMI010, 23EMB432, 23CMH862; ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702; Lot Numbers: 23EBP718, 23EBL801, 23EBD901, 23DBK483; mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920; Lot Numbers: 23EBG158, 23DBP414; nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913; Lot Numbers: 23DBN415; oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157; Lot Numbers: 23EBP436, 23EBD808, 23DBK651; pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773; Lot Numbers: 23DDC201; qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101; Lot Numbers: 23EBU113, 23EBE042, 23CBM408, 23BBR583; rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149; Lot Numbers: 23EBT351, 23EBI750; ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789; Lot Numbers: 23FLA027; tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175; Lot Numbers: 23CMF816; uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369; Lot Numbers: 23DMG164; vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795; Lot Numbers: 23DME833, 23CMG975

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92486
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 7 products (183240 units; 15 units; 144 units; 128 units; 60 units; 1500 units; 4500 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.