—#210183

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

FDA product code: FDE — Laparoscopy Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: 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 (case), Lot Numbers: 23LBO773; 14) REF DYNJ55479D, UDI/DI 40195327416769 (each) 10195327416768 (case), Lot Numbers: 23LBL444; 15) REF DYNJ58445A, UDI/DI 40195327585953 (each) 10195327585952 (case), Lot Numbers: 23LBU911; 16) REF DYNJ58566B, UDI/DI 40195327243228 (each) 10195327243227 (case), Lot Numbers: 23KBC919; 17) REF DYNJ59431, UDI/DI 40888277741257 (each) 10888277741256 (case), Lot Numbers: 24ABG210; 18) REF DYNJ60077A, UDI/DI 40193489862905 (each) 10193489862904 (case), Lot Numbers: 23LBO542; 19) REF DYNJ62111C, UDI/DI 40195327312146 (each) 10195327312145 (case), Lot Numbers: 23LBP204; 20) REF DYNJ65830A, UDI/DI 40195327588732 (each) 10195327588731 (case), Lot Numbers: 23LBR366; 21) REF DYNJ66821A, UDI/DI 40193489974929 (each) 10193489974928 (case), Lot Numbers: 23KBQ852; 22) REF DYNJ68883, UDI/DI 40193489848329 (each) 10193489848328 (case), Lot Numbers: 23KBC527; 23) REF DYNJ69729, UDI/DI 40193489973267 (each) 10193489973266 (case), Lot Numbers: 24ABD664; 24) REF DYNJ80004, UDI/DI 40195327005192 (each) 10195327005191 (case), Lot Numbers: 23LBP094; 25) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 24ABG464; 26) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 23LBU050; 27) REF DYNJ82626, UDI/DI 40195327199488 (each) 10195327199487 (case), Lot Numbers: 24ABN216; 28) REF DYNJ83155, UDI/DI 40195327236855 (each) 10195327236854 (case), Lot Numbers: 23LBV474; 29) REF DYNJ900583M, UDI/DI 40195327061853 (each) 10195327061852 (case), Lot Numbers: 24ABU214; 30) REF DYNJ905569B, UDI/DI 40193489995672 (each) 10193489995671 (case), Lot Numbers: 24ABJ966; 31) REF DYNJ907541A, UDI/DI 40195327054268 (each) 10195327054267 (case), Lot Numbers: 23KBT202; 32) REF LLSCASET01, UDI/DI 40080196120681 (each) 10080196120680 (case), Lot Numbers: 23LBM079; 33) REF SYNJ910011B, UDI/DI 40195327246809 (each) 10195327246808 (case), Lot Numbers: 24ABS212

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Timeline

Recall initiated: 2024-09-04
Posted by FDA: 2024-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210183. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.