Contamination Prompts Recall of Heparin, Saline Syringes
Notice warns of potentially fatal infections from pre-filled flushes
MONDAY, Jan. 21 (HealthDay News) -- An urgent nationwide recall has been issued for all lots of heparin and saline pre-filled flushes marketed under the brand names Sierra Pre-Filled Inc. and B. Braun, according to a Jan. 18 notice issued by AM2PAT Inc., which manufactures the flushes.
One lot of heparin flush syringes has been found to be contaminated with the bacteria Serratia marcescens, resulting in patient infections. Contamination has been confirmed in several unopened syringes. This type of infection can present "a serious adverse health consequence that could lead to life-threatening injuries and/or death," the announcement says.
Use of the recalled Heparin or Saline Lock Flush Solution USP syringes should be discontinued immediately, according to the statement. The manufacturer, AM2Pat Inc. of Angier, N.C., does business as Sierra Pre-Filled Inc. The heparin syringes are sold in 3-milliliter and 5-milliliter sizes, while the saline syringes are sold in 3-milliliter, 5-milliliter and 10-milliliter sizes. Existing inventory of these products should be returned to distributors.
"It appears from an ongoing (U.S.) Food and Drug Administration (FDA) inspection of AM2Pat, Inc.'s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes," the statement said.
Catalog numbers of the recalled products can be obtained at the link below.