Warning
Medline Industries Recalls Medline Convenience Kits: 1) HYSTEROSCOPY
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2111-2026Medical Device
Medline Industries Recalls Medline Convenience Kits: 1) HYSTEROSCOPY
Medline Industries, LP · Class II — Moderate Risk
Product Description
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 7) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 8) VAG HYST PACK, Model Number: DYNJ31344J; 9) VAG HYST PACK, Model Number: DYNJ31344K; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 12) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 13) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 14) LAVH PACK, Model Number: DYNJ36712F; 15) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 16) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 17) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 18) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 19) LAVH - N #668629 -N, Model Number: DYNJ58121C; 20) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 21) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 22) D AND C PACK, Model Number: DYNJ61282B; 23) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 24) PERI GYN, Model Number: DYNJ67708A; 25) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 26) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 27) ANORECTAL PACK, Model Number: DYNJ83560; 28) D&C CDS, Model Number: DYNJ902560I; 29) HYSTEROSCOPY, Model Number: DYNJ903327K; 30) HYSTEROSCOPY, Model Number: DYNJ903475I; 31) ROBOTIC HYST, Model Number: DYNJ903798G; 32) TLH KIT, Model Number: DYNJ908149; 33) LAVH TOTE, Model Number: DYNJ908340; 34) LAVH TOTE, Model Number: DYNJ908340A; 35) LAVH TOTE, Model Number: DYNJ908340B; 36) LAVH TOTE, Model Number: DYNJ908340D; 37) LAVH, Model Number: DYNJ908986; 38) LAVH, Model Number: DYNJ908986A; 39) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 40) LAVH GYN/ONC, Model Number: DYNJ910927; 41) VAG HYST PACK, Model Number: DYNJT3348; 42) LAVH PART B, Model Number: DYNJV0312G
Reason for Recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide - US Nationwide distribution.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database