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U.S. Department of Health and Human Services

Class 2 Device Recall safePICO Samplers Syringes equipped w/safe tip caps

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  Class 2 Device Recall safePICO Samplers Syringes equipped w/safe tip caps see related information
Date Initiated by Firm July 18, 2006
Date Posted August 29, 2006
Recall Status1 Terminated 3 on September 14, 2011
Recall Number Z-1443-06
Recall Event ID 36009
510(K)Number K043143  
Product Classification blood samplers - Product Code JKA
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
800-736-0600
Manufacturer Reason
for Recall		 Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
FDA Determined
Cause 2		 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 reach the firm's Technical Support Department should the customer have any questions concerning the recall letter.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = RADIOMETER MEDICAL APS
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