FDA recall Z-3046-2024

Product

Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ; 7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ; 8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ; 9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ; 10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ; 11) GYN LAP , Pack Number CDS860087L ; 12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ; 13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ; 14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ; 15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ; 16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ; 17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ; 18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ; 19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ;

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.

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3046-2024