Recall Z-1443-06 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Radiometer America Inc
SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pouches. The product subject to recall is identified with the following Part Numbers/Order No: 956-610, 956-612, 956-614, 956-616, and 956-623.
| Date | Aug 29, 2006 (initiated Jul 18, 2006) |
| Status | Terminated |
| Reason | Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps. |
| Root cause | Other |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043143 | SAFEPICO Radiometer Medical Aps, Apr 22, 2005 |