Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a)
FDA device recall Z-0090-2019 · posted 2018-10-09 · Terminated
Recall details
- Recalling firm
- Sterilmed, Inc.
- Reason for recall
- Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
- Action taken
- Sterilmed notified customers on about 09/17/2018, via URGENT MEDICAL DEVICE RECALL letter sent via UPS next day. Instructions included examine inventory for affected devices, remove and return affected devices to Stericycle (3rd party processor), provide recall information to appropriate personnel at the facility, and complete and return the Business Reply Form to Stericycle. For questions, contact Sterilmed's Customer Care Team at (888) 541-0078, Monday through Friday from 7:00 AM to 5:00 PM CST.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- PNH
- Quantity affected
- 218 units
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
- Date initiated
- 2018-09-17
- Date posted
- 2018-10-09
- Date terminated
- 2020-08-04
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Reprocessed Steerable Introducer (K152090) | Sterilmed, Inc. | 2016-03-23 |