Heparin pre-filled syringe recall expanded to include Saline pre-filled flushes
Following a nationwide pre-filled syringe recall which was announced last month for Sierra Heparin Pre-filled Lock Flush Solutions, AM2 PAT, Inc. has now expanded their recall to include all lots of both Heparin and Saline pre-filled syringes manufactured by the company. The prefilled syringes could be contaminated with Serratia marcescens, which is a type of bacteria that may lead to serious injury or death. The lawyers at Saiontz & Kirk, P.A. are reviewing potential pre-filled syringe recall lawsuits for individuals who have suffered a bacterial infection after using the Heparin or Saline Lock Flush Solution.
>>PRIOR POST (1/6/08): Heparin Pre-Filled Syringe Recall
The original pre-filled syringe recall was initiated on December 20, 2007 for one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL syringes). This recall included about 17,000 pre-filled syringes. On January 18, 2008 the recall was expanded to include both Heparin syringes and Saline syringes which could be sold under the brand names “Sierra Pre-Filled” or “B. Braun.” The Heparin pre-filled syringes are sold in 3 mL and 5 mL sizes. The normal Saline pre-filled syringes are sold in 3 mL, 5 mL and 10 mL sizes.
The U.S. Centers for Disease Control and Prevention (CDC) has confirmed that the Serratia marcescens bacteria was present in some of the end user samples of the prefilled syringes. In a press release issued by the FDA, they indicate that the company’s manufacturing facility appears to not be in compliance with federal regulations and that adequate controls were not in place to ensure the sterility of their pre-filled syringes.
The syringe recall applies to all strengths and sizes of Heparin Lock Flush Solution USP and Saline Lock Flush Solution USP, which could be provided with the following information on the label.
| LOT # | NDC # | CATALOG # | Product Brand Name |
| All | 64054-1003-02 | 1003-02 | Heparin Lock Flush 100units/ml 5ml |
| 64054-1003-01 | 1003-01 | Heparin Lock Flush 100units/ml 3ml | |
| 64054-3005-02 | 3005-02 | Heparin Lock Flush 10units/ml 5ml | |
| 64054-3003-02 | 3003-02 | Heparin Lock Flush 10units/ml 3ml | |
| 64054-3003-06 | 3003-06 | Heparin Lock Flush 10units/mL 3ml (6ml syringe) | |
| 64054-3005-06 | 3005-06 | Heparin Lock Flush 10units/mL 5ml (6ml syringe) | |
| 64054-0910-2 | 0910-12 | Normal Saline Flush 10ml | |
| 64054-0905-2 | 0905-12 | Normal Saline Flush 5ml | |
| 64054-0903-2 | 0903-12 | Normal Saline Flush 3ml |
PRE-FILLED SYRINGE RECALL LAWSUITS
The lawyers at Saiontz & Kirk, P.A. are investigating potential Saline and Heparin syringe lawsuits for any individuals who received one of the pre-filled syringes and subsequently developed a bacterial infection. Symptoms of infection caused by the Serratia marcescens bacteria could include:
- Fever
- Chills
- Shaking
- Vomiting
If you, a friend or family member experienced problems requiring medical treatment after using a Saline or Heparin pre-filled syringe, request a free consultation and claim evaluation.
3 Comments • Add Your Comments
B Moeller says:
I have been exposed to this heparin lot number and also the saline brand. I still hold in my possion 12 individual pre packaged heparin syringes.And a few individual packaged saline syringes.I live in jacksonville florida.
Posted on February 21, 2008 at 8:51 pm
Vicki says:
was using the batch lot that was tested by the FDA Lot # 070917A. I was using a PICC line that was flushed six times a day and I also had an open incission from a Lumpectomy that was left to heal from the inside out, that was flushed twice a day and the open incission packed. I used 45 of these saline solutions syringes and had a severe allergic reaction and had to have the PICC Line removed on 2/10/08 then developed another infection in my left breast and underwent another surgery on 2/18/08 due to the bacteria from the saline solutions.
I am recovering from the surgery now with a drainage tube in my side to drain any infection left in my breast.
I just wanted someone to know what I have went through with the pre-filled syringes.
This has been a painful process, one that I hope will soon be behind me
Posted on February 22, 2008 at 7:00 pm
Jennifer says:
Does anyone know if these products were distributed in Ontario Canada? My father survived 13 months after contracting serratia marcescens during open heart surgery. The hospital has provided me with 500 pages of records that are void of products and drugs administered. They stonewalled me until August of 2009.
Posted on January 4, 2010 at 1:52 am