Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY… — Class II medical device recall Z-1591-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-23, distributed nationwide. There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile co
| Recall number | Z-1591-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-03-03 |
| Classified | 2025-04-17 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, PA |
| Quantity | 4,022 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489241716, 10195327001117, 10195327140496, 10195327156312, 10195327330903, 10195327455392, 10195327517748, 10198459078699, 10198459100109, 10198459134456, 10884389653210, 10888277077089, 10888277086685, 10888277858114, 10889942493524, 10889942572007, 10889942753130, 40193489241717, 40195327001118, 40195327140497, 40195327156313, 40195327330904, 40195327455393, 40195327517749, 40198459078690 and 9 more |
| Lot numbers | 24IBS428, 24JBM450, 24JBM593, 24JBN316, 24JBN784, 24JBU509, 24JBW818, 24JBX138, 24JBY293, 24KBA200, 24KBA758, 24KBB397, 24KBB454, 24KBC186, 24KBC962, 24KBE652, 24KBF965, 24KBG499, 24KBG961, 24KBH847 |
| Model numbers | 00-398650AJ, 0M-CP01029D, DYNDH1228, DYNJ24812D, DYNJ39515A, DYNJ41932I, DYNJ43969, DYNJ45020, DYNJ51240A, DYNJ51338C, DYNJ64354A, DYNJ69135A, DYNJ69974, DYNJ81454B, DYNJ83961A, DYNJ85070, HCP075G |
Product
Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH PACK, Model Number: DYNJ51338C; 6) BRISTOL MYELOGRAM, Model Number: DYNDH1228; 7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A; 8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 9) CATH LAB PACK, Model Number: DYNJ85070; 10) CT SCAN PACK, Model Number: DYNJ39515A; 11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ; 12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D; 13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974; 14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A; 15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020; 16) PORTACATH PACK, Model Number: DYNJ51240A; 17) RADIOLOGY PACK, Model Number: DYNJ43969; 18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I; 19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B
Reason for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1591-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.