Recall Z-0161-2025
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) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B
Codes / lots: 1) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 24ABW238; 2) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 23KBU714; 3) REF DYNJ25834B, UDI/DI 40193489849555 (each) 10193489849554 (case), Lot Numbers: 24ABG332; 4) REF DYNJ35569C, UDI/DI 40195327498253 (each) 10195327498252 (case), Lot Numbers: 23LBL736; 5) REF DYNJ40724D, UDI/DI 40195327420773 (each) 10195327420772 (case), Lot Numbers: 24ABG713; 6) REF DYNJ41105C, UDI/DI 40193489969659 (each) 10193489969658 (case), Lot Numbers: 24ABA628; 7) REF DYNJ42132A, UDI/DI 40195327385270 (each) 10195327385279 (case), Lot Numbers: 23LBS108; 8) REF DYNJ43380A, UDI/DI 40888277265913 (each) 10888277265912 (case), Lot Numbers: 23KBD028; 9) REF DYNJ46716, UDI/DI 40888277597069 (each) 10888277597068 (case), Lot Numbers: 23LBM976; 10) REF DYNJ47821F, UDI/DI 40193489956796 (each) 10193489956795 (case), Lot Numbers: 24ABC507; 11) REF DYNJ48978C, UDI/DI 40195327325948 (each) 10195327325947 (case), Lot Numbers: 23LBP883; 12) REF DYNJ50428C, UDI/DI 40195327504039 (each) 10195327504038 (case), Lot Numbers: 23LBN301; 13) REF DYNJ53418B, UDI/DI 40195327372270 (each) 10195327372279…
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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-0161-2025
- Initiated
- September 4, 2024
- Posted by FDA
- October 23, 2024
- Product code
- FDE – Laparoscopy Kit
- Quantity
- 5972 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-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-0166-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF…XXX | 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 |