Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 St
FDA device recall Z-0623-2017 · posted 2016-11-18 · Terminated
Recall details
- Recalling firm
- Greatbatch Medical
- Reason for recall
- Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.
- Action taken
- Greatbatch sent a "Urgent Medical Device Recall" letter dated September 7, 2016 to all affected customers .The letter described the product, "Reason for Field Correction Action", "Risk to Health" , "Replacement Devices", & "Instructions to Customers" . Advised customers to quarantine the product and contact end users and share the recall information with them. Requested consignees to complete & return the Field Recall Response Form. For questions contact your local Greatbatch Medical representative, contact us at 1-763-951-8235, or e-mail us at FieldActionCenter@Greatbatch.com.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 23,075
- Distribution
- US: NY, TX.
- Date initiated
- 2016-09-08
- Date posted
- 2016-11-18
- Date terminated
- 2017-09-08
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STIFFER COAXIAL MICRO-INTRODUCER KIT (K071574) | Enpath Medical, Inc. | 2007-07-05 |