St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm,
FDA device recall Z-0213-2018 · posted 2017-12-29 · Terminated
Recall details
- Recalling firm
- Sterilmed Inc
- Reason for recall
- Inadequate seal due to lack of adhesive glue
- Action taken
- Sterilmed sent an Urgent Medical Device Recall letter dated June 12, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory to determine if affected products are on hand, complete and return the Business Reply Form, share information with appropriate staff in facility, attach copy of this notification to quarantined product, and return affected product to Sterilmed. For questions contact Sterilmed's Customer Care Team at 888-541-0078.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 112 devices
- Distribution
- US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
- Date initiated
- 2017-06-02
- Date posted
- 2017-12-29
- Date terminated
- 2019-07-29
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Reprocessed Steerable Introducer (K152090) | Sterilmed, Inc. | 2016-03-23 |