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.
FDA Recall Z-1443-06 · Posted 2006-08-29
Advertisement
Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeJKA
Date Initiated2006-07-18
Date Terminated2011-09-14
Product Quantity448 boxes x 100 per box [44,800 pouches]
Reason for Recall
Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
Firm 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 reach the firm's Technical Support Department should the customer have any questions concerning the recall letter.
Root Cause
Other
Distribution Pattern
Nationwide distribution --- including the states of MO, WI, DC, FL, MI, CA, CO, GA, KS, KY, PA, TX, and SD.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement