Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package
FDA device recall Z-1121-2015 · posted 2015-02-17 · Terminated
Recall details
- Recalling firm
- Pulsion Medical Inc
- Reason for recall
- Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
- Action taken
- Pulsion sent an Urgent Medical Device Recall notification letter on 11/04/14 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers where instructed to: " Piease examine your inventory immediately to determine if you have any of the products listed. " lf so, please remove the affected products; quarantine them in a secure location. " Piease complete and return the enclosed Field Recall Response Form, acknowleding your receipt and understanding of this communication " Send all affected products back to PULSION Medical Systems. " Upon return of the affected product you will receive a credit note. For questions contact your PULSION Medical lnc Recall Coordinator.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KRB
- Quantity affected
- 90 units
- Distribution
- US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
- Date initiated
- 2014-11-04
- Date posted
- 2015-02-17
- Date terminated
- 2015-10-02
- Location
- Powell, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR (K991886) | Pulsion Medical Systems, Inc. | 2000-05-11 |