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.
This recall has been terminated (originally issued August 29, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- July 18, 2006
- Posted
- August 29, 2006
- Terminated
- September 14, 2011
- Recall Number
- Z-1443-06
- Quantity
- 448 boxes x 100 per box [44,800 pouches]
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
Distribution
Nationwide distribution --- including the states of MO, WI, DC, FL, MI, CA, CO, GA, KS, KY, PA, TX, and SD.
Lot / Code Info
The recalled product is identified with the following Part Numbers/Order No.; Lot Numbers; and Expiration Dates: Part #956-610, Lot #RD-28, and Expiration Date: 2008-01; Part #956-612, Lot #RJ-05, and Expiration Date: 2008-02; Part #956-614, Lot #RL-30, Expiration Date: 2008-03, Part #956-616, Lot #RQ-02, Expiration Date: 2008-04; and Part #956-623, Lot Code: RL22, and Expiration Date:2008-03
Root Cause
Other
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.