Description of Event or Problem · 1
I USE WILLOW BRAND BREAST MILK PUMPING AND STORAGE BAGS WITH THE WILLOW BREAST PUMP. I RECENTLY RETURNED TWO ORDERS OF BAGS (APPROXIMATELY 250 BAGS IN TOTAL) BECAUSE THEY APPEARED CONTAMINATED WITH FINE WHITE/GREY PARTICLES. I QUESTIONED DUST, PLASTIC PARTICLES FROM THE BAGS BEING CUT, OR SOME OTHER MANUFACTURING RESIDUE. THE COMPANY COULD NOT CONFIRM WHAT THE CONTAMINANT WAS HOWEVER, THEY ADVISED THAT I COULD FEED MY INFANT SON THE MILK STORED IN THESE BAGS. I EXPLAINED I WOULD NOT BE DOING THAT UNTIL THEY COULD CONFIRM WHAT THE "DUST" WAS. I WAS SENT REPLACEMENT BAGS AS WELL AS AN ALTERNATIVE PLASTIC CONTAINER COMPATIBLE WITH THE PUMP TO USE. IN THE NEW PACK OF BAGS, THERE ARE STILL MANY BAGS WITH THE SAME RESIDUE/DUST PRESENT. I HAVE REACHED OUT AGAIN TO THE COMPANY FOR AN UPDATE. THEY STATE THEY ARE NOT AWARE OF ANY QUALITY ISSUES WITH THE BAGS AND THAT IT COULD TAKE SOME TIME FOR THE COMPANY TO LOOK INTO THIS. I DID EXPLAINED I WOULD NEED TO TRASH ALMOST MY ENTIRE SUPPLY OF STORED BREAST MILK BECAUSE OF THIS. I DID KEEP A FEW OF THE BAGS WITH THE DUST IN THEM, AND I WAS NOT SURE WHERE I SHOULD GO TO HAVE THEM EVALUATED OR EVEN IF I COULD HAVE THIS DONE AS A CONSUMER. WHEN I REACHED OUT TO A WILLOW PUMP SPECIFIC SUPPORT GROUP, MANY OF THE MEMBERS STATE THAT THEIR BAGS APPEAR CONTAMINATED IN THE SAME WAY. I HAVE ANOTHER BRAND OF BAG FOR WHEN I NEED TO STORE PUMPED MILK AND THEY HAVE ALWAYS BEEN 100% CLEAN/NO RESIDUE OF ANY KIND INSIDE AND TO MY KNOWLEDGE, MILK STORED FOR INFANT FEEDING SHOULD BE STORED IN A STERILE BAG. I AM CONCERNED BECAUSE THESE BAGS ARE DEFINITELY NOT CLEAN/STERILE AND MY SON'S GROWTH PERCENTILE HAS DROPPED SINCE I HAVE BEEN USING THE BAGS DESPITE TAKING IN ADEQUATE BREAST MILK. I AM CONCERNED THAT IT COULD BE RELATED AND THUS HAVE STOPPED USING THE BAGS FOR PUMPING. FDA SAFETY REPORT ID# (B)(4).