SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic p
FDA device recall Z-1443-06 · posted 2006-08-29 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
- Action taken
- The firm sent a recall letter to their customers on 7/18/2006. The letter identifies the problem, as well as the Part Numbers and Lot Numbers for the defective safePICO syringes subject to recall. The letter requests that the customers: 1) Examine their inventories for the presence of the affected part numbers and lot numbers; 2) Identify and discard any of the affected product found on-hand; and 3) Return the attached FAX FORM indicating the amount of replacement product required and the address to which the replacement product should be mailed. The letter also provides a telephone number to reach the firm's Technical Support Department should the customer have any questions concerning the recall letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 448 boxes x 100 per box [44,800 pouches]
- Distribution
- Nationwide distribution --- including the states of MO, WI, DC, FL, MI, CA, CO, GA, KS, KY, PA, TX, and SD.
- Date initiated
- 2006-07-18
- Date posted
- 2006-08-29
- Date terminated
- 2011-09-14
- Location
- Westlake, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SAFEPICO (K043143) | Radiometer Medical Aps | 2005-04-22 |