Recall Z-0166-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated September 4, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS; 7) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS; 8) CUSTOM KIT, REF DYNDA2060; 9) CHEST TRAY PACK, REF DYNDA2203; 10) PK LESION CSTM, REF DYNDA2914; 11) BRONCH ESOPHAGOSCOPY PACK, REF DYNDH1765; 12) SOFT TISSUE PACK, REF DYNJ00017M; 13) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 14) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 15) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 16) MINOR PACK-LF, REF DYNJ0410060S; 17) CYSTO I TRAY, REF DYNJ14063D; 18) CYSTO I TRAY, REF DYNJ14063D; 19) CYSTO PACK, REF DYNJ17310D; 20) DENTAL PK-LF, REF DYNJ21241D; 21) CYSTO PACK-LF, REF DYNJ25042I; 22) BASIC PACK-LF, REF DYNJ25450I; 23) BASIC PACK-LF, REF DYNJ25450J; 24) OPS T&A PACK, REF DYNJ26876F; 25) BASIC PACK, REF DYNJ31835G; 26) DENTAL PACK, REF DYNJ32991C; 27) MEDVET PROCEDURE PACK, REF DYNJ34226C; 28) MEDVET PROCEDURE PACK, REF DYNJ34226C; 29) CYSTO, REF DYNJ34527B; 30) UNIVERSAL PACK, REF DYNJ35593D; 31) T&A PACK, REF DYNJ36434A; 32) ENSEMBLE PROCEDURE MINEURE-LF, REF DYNJ38085C; 33) TYMPANOMASTOID PACK, REF DYNJ39342C; 34) OB DELIVERY PACK, REF DYNJ39377C; 35) PK,ENT-T&A, REF DYNJ39548A; 36) PACEMAKER SET UP PACK-LF, REF DYNJ40010B; 37) GENERAL OVERBED PACK, REF DYNJ40045B; 38) GENERAL OVERBED PACK, REF DYNJ40045B; 39) MAJOR OPHTHALMIC, REF DYNJ40317; 40) ENSEMBLE ACCOUCHEMENT-LF, REF DYNJ40933A; 41) ORL TYMPANO PACK BJC-LF, REF DYNJ41674A; 42) TURP PACK BWH-LF, REF DYNJ41706C; 43) TURP PACK BWH-LF, REF DYNJ41706C; 44) CYSTOSCOPY PACK BWH-LF, REF DYNJ41709B; 45) ORAL SURGERY PACK WRO-LF, REF DYNJ41862C; 46) MAJOR CYSTO PACK WRO-LF, REF DYNJ41871B; 47) BASIC SET UP TRAY-LF, REF DYNJ42142A; 48) CHEST TUBE, REF DYNJ42491; 49) BASIC PACK-LF, REF DYNJ43400C; 50) ENT PACK, REF DYNJ43538B; 51) MGASC MINOR PK-22025183, REF DYNJ44818D; 52) GEN SURG - MINOR-LF, REF DYNJ45731A; 53) STERILE FIELD, REF DYNJ46227B; 54) STERILE FIELD, REF DYNJ46227B; 55) BASIC PACK, REF DYNJ47823C; 56) MINOR PACK, REF DYNJ49825C; 57) CYSTO PACK, REF DYNJ50073B; 58) CYSTO PACK, REF DYNJ50073B; 59) 7497 VAT SURGICAL KIT, REF DYNJ50320B; 60) ENSEMBLE CYSTOSCOPIE-LF, REF DYNJ50946A; 61) ENT PACK, REF DYNJ51360; 62) PK-GEN-BASIC, REF DYNJ52220A; 63) MINOR PACK, REF DYNJ52782C; 64) LEG ROLL KIT, REF DYNJ53020; 65) CYSTO PACK-LF, REF DYNJ53204A; 66) TREATMENT ROOM TRAY-LF, REF DYNJ53268; 67) BASIC SET UP PK, REF DYNJ53509B; 68) T AND A PACK, REF DYNJ54087A; 69) TUR PACK, REF DYNJ54483A; 70) FTMC LOCAL PACK-LF, REF DYNJ54607B; 71) TONSIL PACK, REF DYNJ54765C; 72) SPINAL CORD STIMULATION, REF DYNJ57294; 73) T&A PACK, REF DYNJ57810; 74) PROCEDURE PACK, REF DYNJ58538; 75) ENSEMBLE MAIN/POIGNET, REF DYNJ59375; 76) MINOR PACK, REF DYNJ59621A; 77) CYSTO, REF DYNJ60307A; 78) MEDVET PROCEDURE PACK, REF DYNJ60368B; 79) DR. HUNT PACK, REF DYNJ61218; 80) CYSTO PACK, REF DYNJ61506A; 81) SLCH DIGITAL XRAY PACK, REF DYNJ61664A; 82) MHPB CONVERSION PACK, REF DYNJ62027A; 83) SMALL PROCEDURE PACK, REF DYNJ62231; 84) DENTAL PACK, REF DYNJ62619A; 85) BASIC PACK-LF, REF DYNJ63522A; 86) BASIC PACK, REF DYNJ64865; 87) INFERTILITY PACK, REF DYNJ65720; 88) SETUP PACK, REF DYNJ67675A; 89) TLPO PACK, REF DYNJ68312; 90) SURGERY PACK, REF DYNJ68458; 91) KF PACK 2.0, REF DYNJ69619; 92) SURGERY PACK, REF DYNJ69692; 93) DR GREEN PACK, REF DYNJ80043; 94) DRAPE PACK II, REF DYNJ80154B; 95) UNIVERSAL PACK, REF DYNJ80178A; 96) GENERAL SURGERY PACK, REF DYNJ80194; 97) SUPPLEMENT MIPS PK, REF DYNJ80244C; 98) UNIVERSAL PACK, REF DYNJ80401A; 99) UNIVERSAL PACK, REF DYNJ80401A; 100) LITHOTOMY PACK, REF DYNJ80765; 101) PKY LITHOTOMY PACK, REF DYNJ81656A; 102) SOFT TISSUE PACK, REF DYNJ82029; 103) MAJOR SURGI
Codes / lots: 1) REF 00-400616J, UDI/DI 40193489592246 (each), 10193489592245 (case), Lot Numbers: 24ABI725; 2) REF 3706WHST, UDI/DI 40193489445702 (each), 10193489445701 (case), Lot Numbers: 24ABG100; 3) REF CDS980427J, UDI/DI 40889942823575 (each), 10889942823574 (case), Lot Numbers: 24DBG751; 4) REF CDS984603, UDI/DI 40884389853789 (each), 10884389853788 (case), Lot Numbers: 24BBB784; 5) REF CHT745, UDI/DI 40653160263655 (each), 10653160263654 (case), Lot Numbers: 23LBM800; 6) REF DYND150814TS, UDI/DI 40195327149704 (each), 10195327149703 (case), Lot Numbers: 23KBD258; 7) REF DYND150814TS, UDI/DI 40195327149704 (each), 10195327149703 (case), Lot Numbers: 23KBA940; 8) REF DYNDA2060, UDI/DI 40889942697336 (each), 10889942697335 (case), Lot Numbers: 24ABN606; 9) REF DYNDA2203, UDI/DI 40889942813774 (each), 10889942813773 (case), Lot Numbers: 24ABD615; 10) REF DYNDA2914, UDI/DI 40195327092802 (each), 10195327092801 (case), Lot Numbers: 23LBL366; 11) REF DYNDH1765, UDI/DI 40195327205769 (each), 10195327205768 (case), Lot Numbers: 24ABG092; 12) REF DYNJ00017M, UDI/DI 40195327492039 (each), 10195327492038 (case), Lot Numbers: 24ABD093; 13) REF DYNJ0259819I, UDI/DI 40193489972901 (each)…
Reason for recall
XXX
FDA-determined cause: Under Investigation by firm
Action taken
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.
Details
- Recall number
- Z-0166-2025
- Initiated
- September 4, 2024
- Posted by FDA
- October 23, 2024
- Product code
- LRO – General Surgery Tray
- Quantity
- 22,327 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0148-2025 Class II | Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0149-2025 Class II | Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0150-2025 Class II | Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0151-2025 Class II | Centurion OB TRAY, REF MNS13965A; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0152-2025 Class II | Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0153-2025 Class II | Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0154-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0155-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0156-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C -…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0157-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0158-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0159-2025 Class II | Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0160-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0161-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0162-2025 Class II | Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0163-2025 Class II | Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0164-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0165-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0167-2025 Class II | Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0168-2025 Class II | Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0169-2025 Class II | Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0170-2025 Class II | Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0171-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0172-2025 Class II | Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0173-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0174-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0175-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0176-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0177-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0178-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |