—#208631

Product

Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ66109A ; 6) PERINEAL PACK , Pack Number DYNJ69895; 7) LIVER 2018, Pack Number DYNJ905655A; 8) UROLOGY PACK, Pack Number DYNJT2255M

FDA product code: FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: CDS983922F , Lot Number 19BDC122 ; CDS983922F , Lot Number 19CDC327 ; CDS983922F , Lot Number 19EDB619 ; CDS983922F , Lot Number 19HDB982 ; CDS983922F , Lot Number 19JDA589 ; CDS983922F , Lot Number 19JDC196 ; CDS983922F , Lot Number 20DDB450 ; CDS983922F , Lot Number 20FDB626 ; CDS983922F , Lot Number 20GDA441 ; CDS983922F , Lot Number 20HDA774 ; CDS983922F , Lot Number 20IDA727 ; CDS983922F , Lot Number 20JDC665 ; CDS983922F , Lot Number 21DDB315 ; DYNJ27442U , Lot Number 21HBM391 ; DYNJ27442U , Lot Number 21KBS771 ; DYNJ27442U , Lot Number 21LBY698 ; DYNJ39700B , Lot Number 20CBK667 ; DYNJ39700B , Lot Number 20DBC549 ; DYNJ39700B , Lot Number 20IMA568 ; DYNJ39700B , Lot Number 20KMA519 ; DYNJ39700B , Lot Number 20LME505 ; DYNJ39700B , Lot Number 21DMD882 ; DYNJ39700B , Lot Number 21FMC569 ; DYNJ39700B , Lot Number 21FMF531 ; DYNJ39700B , Lot Number 21GMF302 ; DYNJ39700B , Lot Number 21HMD242 ; DYNJ39700B , Lot Number 21JMH252 ; DYNJ39700B , Lot Number 21KMF491 ; DYNJ39700B , Lot Number 22AMG337 ; DYNJ44109B , Lot Number 21IMF271 ; DYNJ44109B , Lot Number 21JMD783 ; DYNJ44109B , Lot Number 21KME283 ; DYNJ66109A , Lot Number 21JBN809 ; DYNJ66109A , Lot Number 21KBC511 ; DYNJ66109A , Lot Number 22CBP867 ; DYNJ69895, Lot Number 21KBU119 ; DYNJ69895, Lot Number 22EBD392 ; DYNJ69895, Lot Number 22GBH506 ; DYNJ905655A, Lot Number 21ILA013 ; DYNJ905655A, Lot Number 21ILA926 ; DYNJ905655A, Lot Number 21JLB171 ; DYNJ905655A, Lot Number 22ALA375 ; DYNJ905655A, Lot Number 22BLA544 ; DYNJ905655A, Lot Number 22CLB377 ; DYNJ905655A, Lot Number 22ELA391 ; DYNJT2255M , Lot Number 21IMF282 ; DYNJT2255M , Lot Number 21JMC072 ; DYNJT2255M , Lot Number 21JMI117 ; DYNJT2255M , Lot Number 21KMF688 ; DYNJT2255M , Lot Number 21KMG176

Why it was recalled

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-04-08
Posted by FDA: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208631. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.