West Palm Beach, Florida Personal Injury Lawyers
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Contaminated Heparin Syringes
On December 20, 2007, Am2Pat, Inc., recalled one lot of prefilled heparin flush syringes (http://www.fda.gov/oc/po/firmrecalls/am2pat12_07.html).
That recall was later expanded to apply to all prefilled heparin and saline flush syringes made by Am2Pat. These syringes were manufactured by Am2Pat and may be labeled as: Am2Pat, Sierra Pre-filled, or B. Braun. These products will all bear the National Drug Code or NDC prefix of: 64054. They were distributed to in-patient and out-patient facilities and directly to patients by home-care companies.
Problems with pre-filled heparin and saline syringes used to flush out long-term IV lines began to surface in October 2007. Blood infections developed in patients who used these syringes that were manufactured by AM2PAT, Inc. at its North Carolina facility. AM2PAT focused its attention on a single lot and related infections in Illinois and Texas. Accordingly, AM2PAT began quarantining this lot and withdrawing syringes from the market. Subsequently, the FDA became involved. It inspected the AM2PAT manufacturing facility and determined the facility failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.
All pre-filled heparin and saline syringes manufactured by AM2PAT, Inc. have been recalled for potential contamination with serratia marcescens bacteria. The recall applies to the heparin pre-filled and saline pre-filled syringes distributed under three product labels: Sierra Pre-Filled, AM2PAT, and B. Braun.
If you or a family member have suffered illness as a result of the use of a contaminated Heparin or Saline syringe, please contact a Florida drug injury attorney at our office at (800) 443-4529 or (561) 684-6330 to discuss how we may be able to assist you. Or fill out the form on the left side of this page and your inquiry will be sent by e-mail to our office.