FDA Device recall Z-2576-2018
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-…
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-… by Arrow International, citing product contains dry natural rubber latex. Label states Latex Free.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2576-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-23 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | PR |
Product
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Reason
Product contains dry natural rubber latex. Label states Latex Free.
Identifiers
| code_info | Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2576-2018%22
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