ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (A
FDA device recall Z-0605-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- SALTER LABS
- Reason for recall
- Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).
- Action taken
- The firm notified the three affected customers directly by phone, followed by a recall form for each direct customer indicating the product, part number, lot number and shipment date and customer order specific for each firm. Customers were to complete and return the form to the fax number listed or call a Customer Service Representative at 1-800-628-4690.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 240 cases
- Distribution
- Nationwide Distribution -- TX and VA.
- Date initiated
- 2011-12-07
- Date posted
- 2012-01-11
- Date terminated
- 2012-01-09
- Location
- Arvin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA (K892406) | Salter Labs | 1989-07-24 |