Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs,
FDA device recall Z-0360-2014 · posted 2013-11-19 · Terminated
Recall details
- Recalling firm
- SALTER LABS
- Reason for recall
- It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.
- Action taken
- Salter Labs called the five customers that received product from the three lots, then follow-up immediately by sending a recall notification letter directly to each customer. Each letter will identify all shipments of subject product that they received. All customers letters were sent certified mail, return receipt requested.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 91 cases (25 units per case)
- Distribution
- Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.
- Date initiated
- 2013-11-01
- Date posted
- 2013-11-19
- Date terminated
- 2013-12-17
- 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 |
|---|---|---|
| SALTER LABS MODEL #4009 SAMPLE LINES (K894350) | Salter Labs | 1989-10-03 |