Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer
FDA device recall Z-2251-2013 · posted 2013-09-18 · Terminated
Recall details
- Recalling firm
- Churchill Medical Systems, Inc.
- Reason for recall
- Microbore tubing disconnecting from male luers on the extension sets.
- Action taken
- "Urgent Medical Device Recall" letters were sent to each customer via courier service on August 12, 2013. Consignees were provided with a description of the issue and instructions on how to handle product that they received and that was further distributed by them. Questions were directed to customer service at 1-800-473-5414.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 13100
- Distribution
- Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
- Date initiated
- 2013-08-12
- Date posted
- 2013-09-18
- Date terminated
- 2014-06-16
- Location
- Dover, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VYGON BIONECTOR WITH EXTENSION SET (K963981) | Vygon Corp. | 1997-02-14 |