Z-2576-2018 Class II Terminated
FDA device recall Z-2576-2018 was initiated by Arrow International Inc on May 23, 2018 and is designated Class II. Reason for recall: Product contains dry natural rubber latex. Label states Latex Free. The recall status is terminated (terminated May 20, 2020). Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- May 23, 2018
- Termination Date
- May 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
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 for Recall
Product contains dry natural rubber latex. Label states Latex Free.
Distribution Pattern
Puerto Rico
Code Information
Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2576-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026