NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C
FDA device recall Z-0393-2017 · posted 2016-11-10 · Terminated
Recall details
- Recalling firm
- Baylis Medical Corp *
- Reason for recall
- The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.
- Action taken
- A recall notification, marked URGENT Voluntary Medical Device Recall was sent by Baylis Medical Company via overnight courier to all customers affected by the recall with an Acknowledgement Form. Customers were asked to examine their inventories, quarantine any affected lots, and complete the attached Acknowledgement Form. The form should be returned to Baylis Medical Company via the instructions provided. Upon receipt, the firm will contact customers with information on how to return affected product. Questions regarding the letter can be directed to the Customer Service Department at 1-800-276-4416.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DXF
- Quantity affected
- 28,093 units
- Distribution
- Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.
- Date initiated
- 2016-10-11
- Date posted
- 2016-11-10
- Date terminated
- 2017-07-10
- Location
- Montreal, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NRG TRANSSEPTAL NEEDLE (K073326) | Baylis Medical Co., Inc. | 2008-05-28 |