FDA recall Z-1444-2025

Product

Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pack Number DYNJ63532; 7) BASIC PACK, Pack Number DYNJ81702; 8) BASIC PACK, Pack Number DYNJ36595D; 9) BASIC PACK, Pack Number DYNJ69250A; 10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C; 11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A; 12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A; 13) CABG PACK, Pack Number DYNJ20114Q; 14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L; 15) CHEST PACK SC-LF, Pack Number DYNJ38051F; 16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B; 17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B; 18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C; 19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B; 20) CSTM PK DRP SURG MIN PK LGRAY, P

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status

Ongoing

Initiation date

2025-02-11

Report date

2025-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2025