Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous
FDA device recall Z-0789-2017 · posted 2016-12-19 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
- Action taken
- Consignees were sent on 11/21/2016 a Smiths Medical "Urgent Medical Device Field Safety Notice: dated November 18, 2016. The letter was addressed to "Clinician who uses the Acuvance2 Safety Catheter". The letter described the Reason for Recall, Risk to Health, and Instructions to Customers. Requested consignees to complete and return the "Urgent Medical Device Field Safety Notice Response Form" within 10 days of receipt. For questions contact Stericycle via email at the smithsmedicalrecall@stericycle.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 26,750
- Distribution
- Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
- Date initiated
- 2016-11-21
- Date posted
- 2016-12-19
- Date terminated
- 2017-08-01
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROTECTIV ACUVANCE IV CATHETER SYSTEM (K012128) | Ethicon Endo-Surgery, Inc. | 2001-08-01 |