FDA Device recall Z-1532-2024
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vasc…
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vasc… by Cook, citing packaging may have low seal strength and not meet peel strength specifications, compromising device sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1532-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-01 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | US |
Product
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JCD6.0-38-20- COONS G04221 9) JCD8.0-38-20- COONS G03927
Reason
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Identifiers
| code_info | Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20- COONS (01)00827002039285(17) 15787236; 2) JCD12.0-38-20- COONS (01)00…Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20- COONS (01)00827002039285(17) 15787236; 2) JCD12.0-38-20- COONS (01)00827002039292(17) 15774752, 15774753; 3) JCD14.0-38-20- COONS (01)00827002039322(17) 15797981, 15784149, 15797975 15797976, 15797982; 4) JCD16.0-38-20- COONS (01)00827002039476(17) 15794190, 15794191, 15808405; 5) JCD18.0-38-20- COONS (01)00827002040519(17) 15794189, 15797973; 6) JCD20.0-38-20- COONS (01)00827002042643(17) 15784152, 15784156, 15784158 15784164, 15794195, 15804033; 7) JCD 38-20- COONS (01)00827002044432(17) 15767086, 15784163, 15794203, 15806060; 8) JCD6.0-38-20- COONS (01)00827002042216(17) 15787237, 15787244 9) JCD8.0-38-20- COONS (01)00827002039278(17) 15797985, 15797999, 15798003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1532-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.