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News & Views

Medical Product Recall

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#1 of 43

     Posted 3/31/09 9:58 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.1 ]    
Mon, 30 Mar 2009 09:24:00 -0500

Medtronic, Inc. announced that the U.S. Food and Drug Administration classified as Class I its voluntary recall action initiated on February 11, 2009 of its BioGlide Ventricular Snap Shunt Catheter (Cat. numbers 27782, 27708 and 27802) -- the cerebral ventricular catheter component of a shunt for the treatment of hydrocephalus.


Click here for Recall Details

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#2 of 43

     Posted 3/31/09 9:34 PM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.2 Message 25421.2 replying to 25421.1 25421.1 ]    
And we now have a Tuesday Evening edition of the Medical Recall list

Caraco Pharmaceutical Laboratories Ltd.

Click here for the official FDA release

The "Blurb" version:
Tue, 31 Mar 2009 12:42:00 -0500

Caraco Pharmaceutical Laboratories, Ltd., a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd.


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#3 of 43

     Posted 4/8/09 8:18 PM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.3 Message 25421.3 replying to 25421.2 25421.2 ]    
Thankfully this thread is not growing like the food Recall list.. This is the 08-April-2009 addition

Wed, 08 Apr 2009 16:02:00 -0500

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

And here is THE LINK to the full announcment by the FDA


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#4 of 43

     Posted 4/14/09 9:02 PM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.4 Message 25421.4 replying to 25421.3 25421.3 ]    
Teleflex Medical announced today that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall initiated on February 2, 2009 by Arrow International's Cardiac Care Division involving volume connectors for its 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters as a Class 1 recall.

Click Here for the full FDA recall announcment
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#5 of 43

     Posted 4/15/09 7:36 PM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.5 Message 25421.5 replying to 25421.4 25421.4 ]    
ION Labs Inc. of Clearwater, FL. is voluntarily recalling all of the Influend Cough and Cold products sold on or after May 30, 2008. ION Labs Inc. is Recalling the listed products due to the products not tested in conformance with the specifications of the lab, therefore the products may have a possibility to be super potent. Possible complications may include Tachycardia, palpitations, arrhythmias, cardiovascular collapse with hypotension, headaches, dizziness, anxiety, restlessness and nervousness.

And here is the LINK to the full text
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#6 of 43

     Posted 5/1/09 12:15 PM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.6 Message 25421.6 replying to 25421.5 25421.5 ]    

Disetronic Medical Systems Inc.Announces a recall of the ACCU-CHEK Spirit insulin pump due to "up" and/or "down" button failures (April 30)
Thu, 30 Apr 2009 14:14:00 -0500

The pumps in question have serial numbers in the range from SN02119552 through SN10006093 (US market).

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#7 of 43

     Posted 5/4/09 10:09 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.7 Message 25421.7 replying to 25421.6 25421.6 ]    

Iovate Health Sciences U.S.A., Inc. Voluntarily Recalls Hydroxycut-Branded Products (May 1)
Mon, 04 May 2009 06:44:00 -0500

Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced that it is voluntarily recalling Hydroxycut branded products sold in the United States.

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#8 of 43

     Posted 5/7/09 10:49 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.8 Message 25421.8 replying to 25421.7 25421.7 ]    

Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test (May 5)
Wed, 06 May 2009 12:28:00 -0500

The recall is limited to the Triage Cardiac Panel, Catalog No. 97000HS, Lot No. W44467B. Biosite Incorporated has notified its customers via overnight mail and has instructed them to discontinue use of the affected lot and discard any remaining product from the lot that is on hand. The identified lot was distributed to clinical labs in the United States between January and February 2009. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot.

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#9 of 43

     Posted 5/9/09 11:42 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.9 Message 25421.9 replying to 25421.8 25421.8 ]    

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall (May 7)
Fri, 08 May 2009 09:09:00 -0500

Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall.

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#10 of 43

     Posted 5/13/09 11:16 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.10 Message 25421.10 replying to 25421.9 25421.9 ]    
13-May, 2009  took 'em 2 days to get me the recall notice!

AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability (May 11)
Tue, 12 May 2009 14:09:00 -0500

A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin.


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#11 of 43

     Posted Jun-3 10:23 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.11 Message 25421.11 replying to 25421.10 25421.10 ]    

Roche Diagnostics notifies customers of the potential for ACCU-CHEK® Softclix 10 and/or 17 count lancets to be uncapped which may lead to an accidental needle stick
Sun, 17 May 2009 23:00:00 -0500

Roche Diagnostics announced today that it is notifying its customers and healthcare professionals about a potential issue with a small number of ACCUCHEK ® Softclix 10 and/or 17 count lancets that have missing caps that were distributed as samples or in the following meter kits...


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#12 of 43

     Posted Jul-11 10:51 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.12 Message 25421.12 replying to 25421.11 25421.11 ]    

Covidien Initiates Nationwide Voluntary Recall of Sodium Chromate Cr-51 Injection, Lot #370-9004
Thu, 09 Jul 2009 20:41:00 -0500

Covidien announced that its Mallinckrodt Inc. subsidiary is voluntarily recalling one lot of Mallinckrodt Sodium Chromate Cr-51 Injection, lot #370-9004 as a result of routine post-market testing in which the product was found to be subpotent.

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#13 of 43

     Posted Jul-11 5:22 PM   
Sysop Dot
 
From  Sysop Dot  Posts 6191  Last Nov-21
To  John in Detroit      [Msg # 25421.13 Message 25421.13 replying to 25421.12 25421.12 ]    
Mallinckrodt Sodium Chromate Cr-51 Injection

Heavens to Betsy!  I used to use that product for blood volume studies, many years ago.  However, we never used a radionuclide on a patient without measuring the dose first.

Dot

Life isn't about waiting for the storm to pass; it's about learning to dance in the rain.

  --Anonymous

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#14 of 43

     Posted Jul-12 9:28 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  Sysop Dot      [Msg # 25421.14 Message 25421.14 replying to 25421.13 25421.13 ]    
I suspect back then DOT, they had not yet layed off their QC inspectors.
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#15 of 43

     Posted Jul-12 11:12 AM   
Sysop Dot
 
From  Sysop Dot  Posts 6191  Last Nov-21
To  John in Detroit      [Msg # 25421.15 Message 25421.15 replying to 25421.14 25421.14 ]    
I suspect back then DOT, they had not yet layed off their QC inspectors.

Probably not.

Dot

Life isn't about waiting for the storm to pass; it's about learning to dance in the rain.

  --Anonymous

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#16 of 43

     Posted Jul-14 10:49 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  Sysop Dot      [Msg # 25421.16 Message 25421.16 replying to 25421.15 25421.15 ]    

Medtronic Voluntarily Recalls Specific Lots of Paradigm® Quick-Set® Infusion Sets In The United States
Mon, 13 Jul 2009 09:15:00 -0500

Medtronic, Inc. has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days.

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#17 of 43

     Posted Jul-17 9:15 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.17 Message 25421.17 replying to 25421.16 25421.16 ]    

Teva Pharmaceuticals USA issues a voluntary user-level nationwide recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B
Thu, 16 Jul 2009 16:40:00 -0500

Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.


Young You Corporation Issues a Voluntary Nationwide Recall of Weight Loss Pills Found to Contain an Undeclared Drug Ingredient
Thu, 16 Jul 2009 19:32:00 -0500

Young You Corporation has been informed by the Food and Drug Administration (FDA) that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss.

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#18 of 43

     Posted Jul-31 9:54 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.18 Message 25421.18 replying to 25421.17 25421.17 ]    

Abbott Issues Voluntary Recall of POWERSAIL® Coronary Dilatation Catheters
Thu, 30 Jul 2009 10:16:00 -0500

Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.


Carefusion Issues Update Regarding Previously Disclosed June 12, 2009 Recall of the Alaris®
Thu, 30 Jul 2009 17:46:00 -0500

CareFusion Corporation, which is expected to become a public company following its planned spinoff from Cardinal Health, today issued the following update regarding its previously disclosed recall of the Alaris System: On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris® System addressing potential risks identified with the Alaris System.

 

Firm Press Release: FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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#19 of 43

     Posted Aug-14 10:29 AM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.19 Message 25421.19 replying to 25421.12 25421.12 ]    

Barr Laboratories, Inc. issues a voluntary nationwide recall of Dextroamphetamine/Amphetamine 20mg Tablets, Lot number 311756
Fri, 14 Aug 2009 08:53:00 -0500

Barr Laboratories, Inc. is initiating a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product identified is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

 

Firm Press Release: FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
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#20 of 43

     Posted Aug-15 3:49 PM   
John in Detroit
 
From  John in Detroit  Posts 2482  Last Nov-21
To  All      [Msg # 25421.20 Message 25421.20 replying to 25421.19 25421.19 ]    
Checking the recall site, these are all medical devices:

Hospira Issues Urgent Device Recall For AC Power Cords
Fri, 14 Aug 2009 19:38:00 -0500

Hospira, Inc. (NYSE: HSP), is initiating a nationwide recall of certain Hospira devices that have defective AC power cords manufactured by Electri-Cord Manufacturing Corporation. This recall is being issued in response to customer reports of sparking, charring and fires on the plug of the power cord.

Firm Press Release: FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. 
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News & Views

Medical Product Recall

  
 
     

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