BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula
FDA device recall Z-0879-2013 · posted 2013-02-26 · Terminated
Recall details
- Recalling firm
- Baylis Medical Company Inc.
- Reason for recall
- A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages
- Action taken
- A recall was initiated on 10/04/2012 and a letter was sent out to the distributor with a Fax-back Acknowledgment Form. The letter described the issue and provided recommendations and a contact number.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- GXI
- Quantity affected
- 1780
- Distribution
- International distribution to the country of Australia.
- Date initiated
- 2012-10-04
- Date posted
- 2013-02-26
- Date terminated
- 2013-05-23
- Location
- Mississauga Canada, Ontario
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BMC RF CANNULA (K972846) | Baylis Medical Co., Inc. | 1998-07-17 |