Recall Z-3070-2026
- Recall number
- Z-3070-2026
- Event number
- 99561
- Firm
- Medline Industries, LP
- Firm FEI
- 1417592
- Product code
- LRO
- Status
- Open, Classified
- Initiated
- 2026-07-20
- Posted
- 2026-08-31
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K213481, K970187, K871434, K890570, K902887, K935741, K935740, K023276, K931758, K980137, K950574, K945831, K872448, K890726, K872011, K914037, K914036, K920267, K932221, K924468, K895202, K931760, K951149, K961863, K920292, K854292, K934428, K874439, K910365, K963443
Product#
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073 DRAWER 4 CIRCULATION ACC011088 DRAWER 5 - LEFT BOX ACC011067 LABOR TRIAGE KIT - LF #13232 DYKM1564 DYKM1564A LINEN UNIVERSAL PACK DYNJT10325 MAC KIT DYKS1089B NICU LINE PACK DYNJ63410 PEDIATRIC BLOOD CULTURE KIT DYNDH1363 RRMC CODE CART DRAWER 3 ACC010770 STANFORD TIME TO POSITIVITY DYNDH1591 STUDENT PRACTICE BAG W LOGO EDUC1043 EDUC1043A SUTURED SHEATH W/SCI #113198 DYKM1496 IV START KIT DYNDV2520
Reason for Recall#
Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.