FDA recall Z-2992-2024

Product

Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400

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-2992-2024