Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Monoject Prefill Advanced

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Monoject Prefill Advanced see related information
Date Initiated by Firm December 06, 2010
Date Posted January 11, 2011
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-0894-2011
Recall Event ID 57463
Product Classification Phlebotomy blood collection kit - Product Code OFM
Product Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL, Manufactured for : Blood Center of Wisconsin, Milwaukee, WI.

Port VAD Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. 3540CL, Manufactured for : McCormick Medical Distribution, Edmonds, WA 98020.
The kits are used by blood centers to draw blood.
Code Information Lot 912024, 1004229, 1007091 (Reorder # Q921CL) Lot 1001066 (Reorder # 3540CL)
Recalling Firm/
Manufacturer		 Continental Medical Labs,Inc
813 Ela Ave / PO Box 306
Waterford WI 53185-0306
For Additional Information Contact
414-534-2787
Manufacturer Reason
for Recall		 Continental Medical labs, Inc, is recalling various lots of Blood Center Kit and Port VAD Kits because Covidien reported that testing could not pick up an Over-Sulfated Chondroitin Sulfate (OSCS) contaminant in the purified heparin sodium USP.
FDA Determined
Cause 2		 Material/Component Contamination
Action Covidien sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to their distributors. Continental Medical Labs,Inc telephoned on 12/06/2010 and later sent a letter dated December 7, 2010, with an enclosed copy of the recall notice. The letters were addressed to McCormick Medical Distribution, Inc and to Medico Mart, Inc. The letter described the problem and product affected. Advised consignees to inform all their customers to return the product as well as the distribution information as soon as possible so CML could notify Covidien for replacements. For questions regarding this recall call (262) 723-6715, ext. 313.
Quantity in Commerce 30 cases, 30 kits per case
Distribution Nationwide Distribution including WA and WI
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.
-
-