Medline medical procedure kits labeled as follows: a) recall
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL LAPAROSCOPY V, REF DYNJS2032D; h) LAP APPY, REF DYNJ902383I; i) LAP CHOLE, REF DYNJ9062767D; j) LAP CHOLE, REF DYNJ907187A; k) MAJOR, REF DYNJ904768B; l) MAJOR, REF DYNJ905520F; m) MAJOR, REF DYNJ907154A; n) MAJOR SURGICAL, REF DYNJ905005C; o) MINOR, REF DYNJ907155A; p) MINOR SET UP, REF DYNJ909748; q) RHYZOTOMY, REF DYNJ902288I;
Why was Medline medical procedure kits labeled as follows: a) recalled?
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) REF DYNJ905000D, UDI/DI 40195327316908 (case), 10195327316907 (unit), Lot Numbers: 23BBG363, 23CBN659, 23GBH840, 23HBE163, 23IBJ724, 23KBW116; b) REF DYKE1462A, UDI/DI 40889942620167 (case), 10889942620166 (unit), Lot Numbers: 22FDC042, 22JDB988, 22LBJ315, 23BBL256, 23CBU426, 23EBH275, 23FBK205, 23IBF933; c) REF DYKE1431B, UDI/DI 40889942632313 (case), 10889942632312 (unit), Lot Numbers: 22EME324, 22FMG304, 22HMH828, 22JMC383, 22LMC594, 23AMH794, 23BMF552, 23CME449, 23DMA460, 23FMF461, 23HMD372, 23JMB833, 23LMC072; d) REF DYKE1623B, UDI/DI 40193489424943 (case), 10193489424942 (unit), Lot Numbers: 22EBN239, 22FBQ906, 22JBS556, 23ABD205, 23DBD052, 23FBD026, 23HBQ564, 23KBQ077; e) REF DYNJ902385I, UDI/DI 40193489978279 (case), 10193489978278 (unit), Lot Numbers: 22IBL707, 23ABF810, 23ABS802, 23CBE830, 23CBM190, 23EBC428, 23FBU051, 23HBV225, 23KBR543; f) REF DYNJ905508G, UDI/DI 40195327269075 (case), 10195327269074 (unit), Lot Numbers: 22LME748, 22LMF477, 22LMI027, 23AMB893, 23AMG865, 23EMA933, 23EMB427, 23GMB051, 23HMI600, 23IMG463, 23KMB250; g) REF DYNJS2032D, UDI/DI 40193489214155 (case), 10193489214154 (unit), Lot Numbers: 22JDA825, 22LDB688, 23HDC128, 23KDA676; h) REF DYNJ902383I, UDI/DI 40193488978590 (case), 10193489978599 (unit), Lot Numbers: 22FBF410, 22FBM118, 22GBV826, 22KBJ795, 22LBB636, 23ABM564, 23DBI048, 23EBJ423, 23FBC990, 23HBS791, 23JBR485, 23KBQ988; i) REF DYNJ9062767D, UDI/DI 40195327511037 (case), 10195327511036 (unit), Lot Numbers: 23JBH731; j) REF DYNJ907187A, UDI/DI 40193489970525 (case), 10193489970524 (unit), Lot Numbers: 22EMH533, 22FME336, 22LMB229, 23AME424, 23AMJ064; k) REF DYNJ904768B, UDI/DI 40195327137183 (case), 10195327137182 (unit), Lot Numbers: 22EMG657, 22FMH099, 22IMA134, 22IMD626, 22JMF012, 23BMC481, 23BMG491, 23EMF946, 23GMB885, 23JMJ232, 23LMD177; l) REF DYNJ905520F, UDI/DI 40195327421367 (case), 10195327421366 (unit), Lot Numbers: 23HME815, 23HMH202, 23IMA899, 23JMC171, 23KMH256; m) REF DYNJ907154A, UDI/DI 40193489970341 (case), 10193489970340 (unit), Lot Numbers: 22FMH851, 22IMA525, 22LMF668, 23BMG402, 23DMD186, 23DME333, 23EMF068, 23HMD762, 23HMH492, 23KMC012; n) REF DYNJ905005C, UDI/DI 40195327316946 (case), 10195327316945 (unit), Lot Numbers: 23ABL864, 23CBF410, 23DBF768, 23GBS885, 23IBD450; o) REF DYNJ907155A, UDI/DI 40193489970273 (case), 10193489970272 (unit), Lot Numbers: 22KME231, 22LME429, 23AMF052, 23EMF507, 23JMA490; p) REF DYNJ909748, UDI/DI 40195327468218 (case), 10195327468217 (unit), Lot Numbers: 23IMI101, 23KMB382; q) REF DYNJ902288I, UDI/DI 40195327442225 (case), 10195327442224 (unit), Lot Numbers: 23GBD871, 23IBT374, 23KBD099;
- Product
- Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL LAPAROSCOPY V, REF DYNJS2032D; h) LAP APPY, REF DYNJ902383I; i) LAP CHOLE, REF DYNJ9062767D; j) LAP CHOLE, REF DYNJ907187A; k) MAJOR, REF DYNJ904768B; l) MAJOR, REF DYNJ905520F; m) MAJOR, REF DYNJ907154A; n) MAJOR SURGICAL, REF DYNJ905005C; o) MINOR, REF DYNJ907155A; p) MINOR SET UP, REF DYNJ909748; q) RHYZOTOMY, REF DYNJ902288I;
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 22891 units
- Distribution
- Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
- Recall date
- August 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)