Medline Industries, LP Recall: Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST,
Medline Industries, LP Recall: Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medline Industries, LP; Product: Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY L
| Recalling firm | Medline Industries, LP |
|---|---|
| Product | Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution - US Nationwide. |
| Recall initiated | 20260107 |
| Recall number | Z-1392-2026 |
| Category | device |
| State | IL |
| Country | United States |
$29/mo
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